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Clinical Trials in China / NCT04639180
Active, not recruiting Phase 3

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

NCT04639180 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 3
Started
2021-04-01
Last updated
2025-12-30

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

CamrelizumabRivoceranib (Apatinib)

Camrelizumab: Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder

Rivoceranib (Apatinib): Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Guangxi Medical University Affiliated Tumor Hospital Nanjin Guangzhou
Guizhou Cancer Hospital Guiyang Guizhou
Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04639180 on ClinicalTrials.gov ↗ ← All trials in China