A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) 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
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess 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
• 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
• 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
• Serious non-healing or dehiscing wound
• Major Curative procedure within four weeks
• Factors to affect oral administration

• 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