Status:
COMPLETED
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
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Recurren...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT05367687
Start Date
September 1 2022
End Date
November 15 2024
Last Update
November 17 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032