NCT03635489

A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed Phase 3 Results posted Last updated 3 October 2024

What this trial tests

Phase 3 trial testing Paclitaxel in Ovarian Cancer in 100 participants. Completed in 11 May 2023.

Timeline

15 August 2018

Primary endpoint
26 May 2021

11 May 2023

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	15 August 2018
Primary completion	26 May 2021
Estimated completion	11 May 2023
Sites	16 locations across China

Drugs / interventions tested

• Paclitaxel — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Placebo

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
• Primary Peritoneal Cancer — all drugs for Primary Peritoneal Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer or Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival (PFS) Primary · Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	12.32	9.53 – 15.05
Bevacizumab + Paclitaxel + Carboplatin	22.57	18.60 – NA

Overall Survival (OS) Secondary · Randomization up to to death from any cause (up to approximately 54.1 months)

OS was defined as the time from the date of randomization to the date of death from any cause.

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	48.89	40.31 – NA
Bevacizumab + Paclitaxel + Carboplatin	NA	NA – NA

Objective Response Rate (ORR) Secondary · Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

ORR was defined as the proportion of participants with complete response (CR) or partial response (PR) as assessed by investigator according to RECIST v.1.1.

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	92.9	76.50 – 99.12
Bevacizumab + Paclitaxel + Carboplatin	95.8	78.88 – 99.89

Duration of Response (DOR) Secondary · From the date of first occurrence of a complete or partial response until disease progression or death from any cause (up to approximately 24 months)

DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression,as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurred first. DOR was evaluated for participants who had a objective response of CR or PR.

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	8.87	7.56 – 13.14
Bevacizumab + Paclitaxel + Carboplatin	16.10	10.81 – NA

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.0	23.21 – 52.45
Bevacizumab + Paclitaxel + Carboplatin	31.3	18.66 – 46.25

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	40.9	26.34 – 56.75
Bevacizumab + Paclitaxel + Carboplatin	42.1	26.31 – 58.18

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	48.4	30.15 – 66.94
Bevacizumab + Paclitaxel + Carboplatin	40.0	23.87 – 57.89

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.5	15.20 – 64.57
Bevacizumab + Paclitaxel + Carboplatin	48.0	27.80 – 68.69

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.8	23.77 – 53.46
Bevacizumab + Paclitaxel + Carboplatin	45.2	29.85 – 61.33

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.0	19.40 – 57.63
Bevacizumab + Paclitaxel + Carboplatin	33.3	18.56 – 50.97

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	33.3	11.82 – 61.62
Bevacizumab + Paclitaxel + Carboplatin	38.1	18.11 – 61.56

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	50.0	15.70 – 84.30
Bevacizumab + Paclitaxel + Carboplatin	46.2	19.22 – 74.87

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	26.1	14.27 – 41.13
Bevacizumab + Paclitaxel + Carboplatin	33.3	20.40 – 48.41

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	36.4	22.41 – 52.23
Bevacizumab + Paclitaxel + Carboplatin	47.4	30.98 – 64.18

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	29.0	14.22 – 48.04
Bevacizumab + Paclitaxel + Carboplatin	31.4	16.85 – 49.29

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	25.0	7.27 – 52.38
Bevacizumab + Paclitaxel + Carboplatin	40.0	21.13 – 61.33

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	33.3	20.00 – 48.95
Bevacizumab + Paclitaxel + Carboplatin	33.3	19.57 – 49.55

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	25.9	11.11 – 46.28
Bevacizumab + Paclitaxel + Carboplatin	33.3	18.56 – 50.97

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	46.7	21.27 – 73.41
Bevacizumab + Paclitaxel + Carboplatin	19.0	5.45 – 41.91

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	25.0	3.19 – 65.09
Bevacizumab + Paclitaxel + Carboplatin	23.1	5.04 – 53.81

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical) Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	17.4	7.82 – 31.42
Bevacizumab + Paclitaxel + Carboplatin	16.7	7.48 – 30.22

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	18.2	8.19 – 32.71
Bevacizumab + Paclitaxel + Carboplatin	18.4	7.74 – 34.33

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	45.2	27.32 – 63.97
Bevacizumab + Paclitaxel + Carboplatin	34.3	19.13 – 52.21

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	43.8	19.75 – 70.12
Bevacizumab + Paclitaxel + Carboplatin	36.0	17.97 – 57.48

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	31.1	18.17 – 46.65
Bevacizumab + Paclitaxel + Carboplatin	31.0	17.62 – 47.09

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	44.4	25.48 – 64.67
Bevacizumab + Paclitaxel + Carboplatin	27.8	14.20 – 45.19

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	13.3	1.66 – 40.46
Bevacizumab + Paclitaxel + Carboplatin	23.8	8.22 – 47.17

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	12.5	0.32 – 52.65
Bevacizumab + Paclitaxel + Carboplatin	23.1	5.04 – 53.81

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role) Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	34.8	21.35 – 50.25
Bevacizumab + Paclitaxel + Carboplatin	31.3	18.66 – 46.25

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	25.0	13.19 – 40.34
Bevacizumab + Paclitaxel + Carboplatin	36.8	21.81 – 54.01

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	45.2	27.32 – 63.97
Bevacizumab + Paclitaxel + Carboplatin	48.6	31.38 – 66.01

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	50.0	24.65 – 75.35
Bevacizumab + Paclitaxel + Carboplatin	40.0	21.13 – 61.33

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	40.0	25.70 – 55.67
Bevacizumab + Paclitaxel + Carboplatin	42.9	27.72 – 59.04

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	48.1	28.67 – 68.05
Bevacizumab + Paclitaxel + Carboplatin	33.3	18.56 – 50.97

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	40.0	16.34 – 67.71
Bevacizumab + Paclitaxel + Carboplatin	42.9	21.82 – 65.98

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.5	8.52 – 75.51
Bevacizumab + Paclitaxel + Carboplatin	30.8	9.09 – 61.43

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social) Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	28.3	15.99 – 43.46
Bevacizumab + Paclitaxel + Carboplatin	29.2	16.95 – 44.06

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	27.3	14.96 – 42.79
Bevacizumab + Paclitaxel + Carboplatin	28.9	15.42 – 45.90

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	38.7	21.85 – 57.81
Bevacizumab + Paclitaxel + Carboplatin	28.6	14.64 – 46.30

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	43.8	19.75 – 70.12
Bevacizumab + Paclitaxel + Carboplatin	36.0	17.97 – 57.48

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	28.9	16.37 – 44.31
Bevacizumab + Paclitaxel + Carboplatin	33.3	19.57 – 49.55

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	33.3	16.52 – 53.96
Bevacizumab + Paclitaxel + Carboplatin	47.2	30.41 – 64.51

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	26.7	7.79 – 55.10
Bevacizumab + Paclitaxel + Carboplatin	28.6	11.28 – 52.18

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	37.5	8.52 – 75.51
Bevacizumab + Paclitaxel + Carboplatin	7.7	0.19 – 36.03

Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional) Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	8.7	2.42 – 20.79
Bevacizumab + Paclitaxel + Carboplatin	22.9	12.03 – 37.31

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	13.6	5.17 – 27.35
Bevacizumab + Paclitaxel + Carboplatin	21.1	9.55 – 37.32

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	9.7	2.04 – 25.75
Bevacizumab + Paclitaxel + Carboplatin	25.7	12.49 – 43.26

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	18.8	4.05 – 45.65
Bevacizumab + Paclitaxel + Carboplatin	28.0	12.07 – 49.39

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	11.1	3.71 – 24.05
Bevacizumab + Paclitaxel + Carboplatin	21.4	10.30 – 36.81

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	22.2	8.62 – 42.26
Bevacizumab + Paclitaxel + Carboplatin	27.8	14.20 – 45.19

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	6.7	0.17 – 31.95
Bevacizumab + Paclitaxel + Carboplatin	38.1	18.11 – 61.56

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	12.5	0.32 – 57.87
Bevacizumab + Paclitaxel + Carboplatin	38.5	13.86 – 68.42

Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL) Secondary · From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Cycle 4 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	19.6	9.36 – 33.91
Bevacizumab + Paclitaxel + Carboplatin	33.3	20.40 – 48.41

Cycle 7 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	34.1	20.49 – 49.92
Bevacizumab + Paclitaxel + Carboplatin	34.2	19.63 – 51.35

Cycle 13 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	38.7	21.85 – 57.81
Bevacizumab + Paclitaxel + Carboplatin	34.3	19.13 – 52.21

Cycle 22 Day 1

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	43.8	19.75 – 70.12
Bevacizumab + Paclitaxel + Carboplatin	44.0	24.40 – 65.07

Treatment Completion / Early Termination Visit

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	31.1	18.17 – 46.65
Bevacizumab + Paclitaxel + Carboplatin	40.5	25.63 – 56.72

Survival Follow Up 3 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	29.6	13.75 – 50.18
Bevacizumab + Paclitaxel + Carboplatin	38.9	23.14 – 56.54

Survival Follow Up 6 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	33.3	11.82 – 61.62
Bevacizumab + Paclitaxel + Carboplatin	28.6	11.28 – 52.18

Survival Follow Up 9 Months

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	12.5	0.32 – 52.65
Bevacizumab + Paclitaxel + Carboplatin	23.1	5.04 – 53.81

Percentage of Participants With Adverse Events (AEs) Secondary · From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)

Group	Value	95% CI
Placebo + Paclitaxel + Carboplatin	100
Bevacizumab + Paclitaxel + Carboplatin	100

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo + Paclitaxel + Carboplatin

Serious: 16/50 (32%)

Deaths: 19/50

Bevacizumab + Paclitaxel + Carboplatin

Serious: 17/49 (35%)

Deaths: 13/49

Serious adverse events (26 terms)

Reaction	System	Placebo + Paclitaxel + Car…	Bevacizumab + Paclitaxel +…
Myelosuppression	Blood and lymphatic system disorders	—	—
Platelet count decreased	Investigations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Neutrophil count decreased	Investigations	—	—
Ileus	Gastrointestinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Granulocytopenia	Blood and lymphatic system disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Femoral hernia	Gastrointestinal disorders	—	—
Mechanical ileus	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—
Subileus	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—
Anaphylactic reaction	Immune system disorders	—	—
Anaphylactic shock	Immune system disorders	—	—
Appendicitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Granulocyte count decreased	Investigations	—	—
Syncope	Nervous system disorders	—	—

Other adverse events (79 terms — click to expand)

Reaction	System	Placebo + Paclitaxel + Car…	Bevacizumab + Paclitaxel +…
Alopecia	Skin and subcutaneous tissue disorders	—	—
Neutrophil count decreased	Investigations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
White blood cell count decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Nausea	Gastrointestinal disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Hypertension	Vascular disorders	—	—
Hypoaesthesia	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Malaise	General disorders	—	—
Pain	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Weight increased	Investigations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Blood alkaline phosphatase increased	Investigations	—	—
White blood cells urine positive	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Fatigue	General disorders	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—
Protein urine present	Investigations	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—
Dizziness	Nervous system disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Myelosuppression	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Asthenia	General disorders	—	—

Most-reported serious reactions: Myelosuppression, Platelet count decreased, Anaemia, Neutrophil count decreased, Ileus, Intestinal obstruction, Granulocytopenia, Abdominal distension.

Data from ClinicalTrials.gov NCT03635489 adverse events section.

Sponsor's own description

This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
2. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
3. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.
   Gaitskell K, Rogozińska E, Platt S, Chen Y, et al · · 2023 · cited 18× · PMID 37185961 · DOI 10.1002/14651858.cd007930.pub3
4. Macrophages in ovarian cancer and their interactions with monoclonal antibody therapies.
   Osborn G, Stavraka C, Adams R, Sayasneh A, et al · · 2022 · cited 15× · PMID 35020853 · DOI 10.1093/cei/uxab020
5. First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial.
   Wu X, Liu J, An R, Yin R, et al · · 2024 · cited 3× · PMID 38872480 · DOI 10.3802/jgo.2024.35.e99