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

Hengrui Medicine

Status and phase

Active, not recruiting

Phase 3

Conditions

Hepatocellular Carcinoma (HCC)

Treatments

Drug: Rivoceranib (Apatinib)

Drug: Camrelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04639180

SHR-1210-III-325

Details and patient eligibility

About

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.

Enrollment

687 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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