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A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Phase 3 trial testing SHR-1210 in Locally Advanced or Metastatic and Unresectable HCC in 543 participants. Completed in 14 June 2023.
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 543 |
| Start date | 10 June 2019 |
| Primary completion | 8 February 2022 |
| Estimated completion | 14 June 2023 |
| Sites | 121 locations across Hong Kong, Italy, Russia, Ukraine, Belgium, Taiwan, Germany, Poland |
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
18 and older, any sex, with Locally Advanced or Metastatic and Unresectable HCC. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
OS was defined as the time from randomization to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Camrelizumab+Rivoceranib Arm | 22.1 | 19.1 – 27.2 |
| Sorafenib Arm | 15.2 | 13.0 – 18.5 |
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Group | Value | 95% CI |
|---|---|---|
| Camrelizumab+Rivoceranib Arm | 5.6 | 5.5 – 7.4 |
| Sorafenib Arm | 3.7 | 3.1 – 3.7 |
ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.
| Group | Value | 95% CI |
|---|---|---|
| Camrelizumab+Rivoceranib Arm | 25 | 20 – 31 |
| Sorafenib Arm | 6 | 3 – 9 |
DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient
| Group | Value | 95% CI |
|---|---|---|
| Camrelizumab+Rivoceranib Arm | 78 | 73 – 83 |
| Sorafenib Arm | 54 | 48 – 60 |
DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
| Group | Value | 95% CI |
|---|---|---|
| Camrelizumab+Rivoceranib Arm | 14.8 | 8.4 – NA |
| Sorafenib Arm | 9.2 | 5.3 – NA |
Time frame: Up to approximately 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Camrelizumab+Rivoceranib Arm | Sorafenib Arm |
|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Immune-mediated hepatitis | Hepatobiliary disorders | — | — |
| Pyrexia | General disorders | — | — |
| Reactive capillary endothelial proliferation | Immune system disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Autoimmune hepatitis | Hepatobiliary disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Immune-mediated enterocolitis | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Reaction | System | Camrelizumab+Rivoceranib Arm | Sorafenib Arm |
|---|---|---|---|
| Hypertension | Vascular disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Reactive capillary endothelial proliferation | Immune system disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Weight decreased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Bilirubin conjugated increased | Investigations | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Blood bilirubin unconjugated increased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Asthenia | General disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
Most-reported serious reactions: Upper gastrointestinal haemorrhage, Neoplasm progression, Malignant neoplasm progression, Aspartate aminotransferase increased, Hepatic encephalopathy, Alanine aminotransferase increased, Blood bilirubin increased, Platelet count decreased.
Data from ClinicalTrials.gov NCT03764293 adverse events section.
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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