Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
CompletedPhase 2Results postedLast updated 31 January 2025
What this trial tests
Phase 2 trial testing Tislelizumab in Esophageal Squamous Cell Carcinoma in 125 participants. Completed in 26 December 2023.
18 and older, any sex, with Esophageal Squamous Cell Carcinoma. 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.
Objective Response Rate (ORR) Assessed by the InvestigatorPrimary· Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter.
CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
30.6
19.6 – 43.7
Arm B: Tislelizumab Plus Placebo
20.6
11.5 – 32.7
Overall SurvivalSecondary· From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
Overall survival (OS) is defined as the time from the date of randomization until the date of death due to any cause.
Median overall survival was estimated using the Kaplan-Meier method. For participants who were still alive at the end of the trial, OS was censored at the last known alive date or the date of data cutoff, whichever was earlier.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
10.2
7.9 – 19.5
Arm B: Tislelizumab Plus Placebo
9.3
6.4 – 14.8
Objective Response Rate Assessed by the Independent Review CommitteeSecondary· Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1.
Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter.
CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions.
PR: At least a 30% decrease in the size of target lesion
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
32.3
20.9 – 45.3
Arm B: Tislelizumab Plus Placebo
25.4
15.3 – 37.9
Progression-free Survival (PFS) Assessed by the Independent Review CommitteeSecondary· From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first.
Median PFS was estimated using the Kaplan-Meier method.
Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
3.6
2.7 – 5.1
Arm B: Tislelizumab Plus Placebo
2.8
1.9 – 6.9
Progression-free Survival (PFS) Assessed by the InvestigatorSecondary· From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Investigator per RECIST v1.1, or death, whichever occurred first.
Median PFS was estimated using the Kaplan-Meier method.
Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
3.4
1.8 – 5.1
Arm B: Tislelizumab Plus Placebo
3.4
1.9 – 4.1
Duration Of Response (DOR) Assessed by the Independent Review CommitteeSecondary· From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first.
Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
14.6
7.2 – NA
Arm B: Tislelizumab Plus Placebo
NA
4.2 – NA
Duration Of Response (DOR) Assessed by the InvestigatorSecondary· From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Investigator per RECIST v1.1, or death, whichever occurred first.
Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
11.3
5.7 – NA
Arm B: Tislelizumab Plus Placebo
NA
4.1 – NA
Disease Control Rate Assessed by the IRC And the InvestigatorSecondary· Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the IRC and the investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter.
CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions.
PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or
Investigator assessment
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
61.3
48.1 – 73.4
Arm B: Tislelizumab Plus Placebo
58.7
45.6 – 71.0
Independent Review Committee
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
64.5
51.3 – 76.3
Arm B: Tislelizumab Plus Placebo
58.7
45.6 – 71.0
Clinical Benefit Rate Assessed by the IRC and the InvestigatorSecondary· Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the IRC and the Investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter.
CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions.
PR: At least a 30% decrease in the size of target lesions, with no progression of n
Investigator Assessment
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
33.9
22.3 – 47.0
Arm B: Tislelizumab Plus Placebo
30.2
19.2 – 43.0
Independent Review Committee
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
32.3
20.9 – 45.3
Arm B: Tislelizumab Plus Placebo
27.0
16.6 – 39.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning ScoresSecondary· Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life
Global Health Status/QOL: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
1.7
-5.6 – 8.9
Arm B: Tislelizumab Plus Placebo
-0.1
-7.5 – 7.4
Global Health Status/QOL: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
0.3
-5.6 – 6.1
Arm B: Tislelizumab Plus Placebo
-2.8
-8.8 – 3.2
Physical Functioning: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-0.5
-4.3 – 3.3
Arm B: Tislelizumab Plus Placebo
1.2
-2.8 – 5.2
Physical Functioning: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-4.4
-11.2 – 2.5
Arm B: Tislelizumab Plus Placebo
-3.9
-11.0 – 3.3
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain ScalesSecondary· Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (saliva swallowing, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems.
Dysphagia: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-5.9
-14.2 – 2.4
Arm B: Tislelizumab Plus Placebo
4.1
-4.7 – 12.8
Dysphagia: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-3.5
-15.4 – 8.5
Arm B: Tislelizumab Plus Placebo
7.3
-5.2 – 19.8
Eating: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-1.6
-6.6 – 3.3
Arm B: Tislelizumab Plus Placebo
-1.3
-6.6 – 4.1
Eating: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-2.8
-9.1 – 3.6
Arm B: Tislelizumab Plus Placebo
6.6
-0.2 – 13.4
Reflux: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
1.9
-4.6 – 8.3
Arm B: Tislelizumab Plus Placebo
-0.4
-7.1 – 6.4
Reflux: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
2.7
-4.8 – 10.1
Arm B: Tislelizumab Plus Placebo
4.0
-3.8 – 11.8
Pain: Cycle 5
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
0.1
-5.5 – 5.6
Arm B: Tislelizumab Plus Placebo
-0.7
-6.5 – 5.1
Pain: Cycle 7
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
-2.1
-7.1 – 3.0
Arm B: Tislelizumab Plus Placebo
3.3
-2.0 – 8.5
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Secondary· From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not.
An SAE is any untoward medical occurrence that, at any dose:
* Resulted in death
* Was life-threatening
* Required hospitalization or prolongation of existing hospitalization
* Resulted in disability/incapacity
* Was a congenital anomaly/birth defect
* Was considered a significant medical AE by the Investigator based on medical judgement.
AEs were considered "rela
Any TEAE
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
58
Arm B: Tislelizumab Plus Placebo
60
TEAE ≥ Grade 3
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
28
Arm B: Tislelizumab Plus Placebo
28
Serious AEs
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
27
Arm B: Tislelizumab Plus Placebo
28
Related SAEs
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
13
Arm B: Tislelizumab Plus Placebo
13
TEAEs Leading to Treatment Discontinuation
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
9
Arm B: Tislelizumab Plus Placebo
10
TEAEs Leading to Death (Excluding Due to Disease Under Study)
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
4
Arm B: Tislelizumab Plus Placebo
4
Any Immune-Mediated AE
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
31
Arm B: Tislelizumab Plus Placebo
21
Immune-Mediated AE ≥ Grade 3
Group
Value
95% CI
Arm A: Tislelizumab Plus Ociperlimab
8
Arm B: Tislelizumab Plus Placebo
3
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from randomization through the end of study; up to 30 months. AEs are reported from first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A: Tislelizumab Plus Ociperlimab
Serious: 27/62 (44%)
Deaths: 39/62
Arm B: Tislelizumab Plus Placebo
Serious: 28/63 (44%)
Deaths: 36/63
Serious adverse events (56 terms)
Reaction
System
Arm A: Tislelizumab Plus O…
Arm B: Tislelizumab Plus P…
Pneumonia
Infections and infestations
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
Oesophageal obstruction
Gastrointestinal disorders
—
—
Death
General disorders
—
—
Malaise
General disorders
—
—
Pyrexia
General disorders
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
Malnutrition
Metabolism and nutrition disorders
—
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Angina unstable
Cardiac disorders
—
—
Arteriosclerosis coronary artery
Cardiac disorders
—
—
Immune-mediated myocarditis
Cardiac disorders
—
—
Myocarditis
Cardiac disorders
—
—
Pericardial effusion
Cardiac disorders
—
—
Tachycardia
Cardiac disorders
—
—
Adrenal insufficiency
Endocrine disorders
—
—
Hypophysitis
Endocrine disorders
—
—
Secondary adrenocortical insufficiency
Endocrine disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Impaired gastric emptying
Gastrointestinal disorders
—
—
Inguinal hernia
Gastrointestinal disorders
—
—
Oesophageal fistula
Gastrointestinal disorders
—
—
Oesophageal stenosis
Gastrointestinal disorders
—
—
Oesophageal ulcer
Gastrointestinal disorders
—
—
Other adverse events (86 terms — click to expand)
Reaction
System
Arm A: Tislelizumab Plus O…
Arm B: Tislelizumab Plus P…
Anaemia
Blood and lymphatic system disorders
—
—
Hypothyroidism
Endocrine disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Weight decreased
Investigations
—
—
Hypoalbuminaemia
Metabolism and nutrition disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Alanine aminotransferase increased
Investigations
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
Fatigue
General disorders
—
—
Aspartate aminotransferase increased
Investigations
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Rash
Skin and subcutaneous tissue disorders
—
—
Asthenia
General disorders
—
—
COVID-19
Infections and infestations
—
—
Upper respiratory tract infection
Infections and infestations
—
—
Lymphocyte count decreased
Investigations
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Pruritus
Skin and subcutaneous tissue disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Blood creatine phosphokinase increased
Investigations
—
—
Insomnia
Psychiatric disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Hypertension
Vascular disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Gastrooesophageal reflux disease
Gastrointestinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Neutrophil count decreased
Investigations
—
—
White blood cell count decreased
Investigations
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
Hypochloraemia
Metabolism and nutrition disorders
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
· Phase 2
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure
· Phase 2
· recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
· Phase 2
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
Other recruiting trials for Esophageal Squamous Cell Carcinoma
Currently open trials in the same condition.
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
· Phase 1
· recruiting
NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N
· Phase 1, PHASE2
· recruiting
NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial
· Phase 1
· recruiting
NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
· Phase 1, PHASE2
· recruiting
NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
· Phase 1
· recruiting
Other BeiGene trials
Trials by the same sponsor.
NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob
· Phase 4
· recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum
· Phase 2
· active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-
· Phase 1
· active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
· Phase 1
· completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 31 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04732494.