A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

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

Official Title
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A Randomized, Open-Label, Multi-Center, Phase 2 Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Conditions
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Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Intervention / Treatment
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* Drug: Camrelizumab、Rivoceranib
* Drug: Camrelizumab


Participation Criteria
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Eligibility Criteria
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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. 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. Previous or current presence of metastasis to central nervous system.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Camrelizumab Plus Rivoceranib (Apatinib) | Drug: Camrelizumab、Rivoceranib<br>* Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.<br>|
| Active Comparator: Control group<br>Camrelizumab | Drug: Camrelizumab<br>* Camrelizumab: 200 mg, intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-Free Survival (RFS), as Determined by the investigator | RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death from any cause (whichever occurs first). | Randomization up to approximately 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFS Rate at 24 and 36 Months, as Assessed by the Investigator |  | Randomization up to 24 months and up to 36 months | 
| Time to Recurrence (TTR) as determined by the investigator | TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC. | Randomization up to approximately 43 months | 
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Randomization up to approximately 43 months | 
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 |  | Randomization up to approximately 43 months |