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

Korábbi kezelés

• History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.
• Severe infection within 4 weeks prior to the start of study treatment.
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
• Previous or current presence of metastasis to central nervous system.

Más betegség

• Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously.
• History of hepatic encephalopathy.
• 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.
• Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy.
• Known genetic or acquired hemorrhage or thrombotic tendency.

Egyéb

• Evidence of residual lesion, recurrence, and metastasis at randomization.
• Moderate-to-severe ascites with clinical symptoms.

• 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.