A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

SHR-1210-III-325

A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.

2021-04-01

2024-07-31

2024-07-31

Active (not recruiting)

Early phase I

687

Inclusion Criteria: * Subjects with a histopathological diagnosis of HCC * Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only) * No previous systematic treatment and locoregional therapy for HCC prior to randomization * Absence of major macrovascular invasion * No extrahepatic spread * Full recovery from Curative resection or ablation within 4 weeks prior to randomization * High risk for HCC recurrence after resection or ablation * For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization * Child-Pugh Class: Grade A * ECOG-PS score: 0 or 1 * Subjects with HCV- RNA (+) must receive antiviral therapy * Adequate organ function Exclusion Criteria: * Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously * Evidence of residual lesion, recurrence, and metastasis at randomization; * Moderate-to-severe ascites with clinical symptoms * History of hepatic encephalopathy * History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage * Active or history of autoimmune disease * Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity * Cardiac clinical symptom or cardiovascular disease that is not well controlled * Severe infection within 4 weeks prior to the start of study treatment * HIV infection * Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy * Thrombosis or thromboembolic event within 6 months prior to the start of study treatment * Known genetic or acquired hemorrhage or thrombotic tendency * Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * Serious non-healing or dehiscing wound * Major Curative procedure within four weeks * Factors to affect oral administration * Previous or current presence of metastasis to central nervous system

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 687, 'type': 'ACTUAL'}}

2023-04-25