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
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)
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) — Randomization up to approximately 43 months RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Trial sites (6)
Facility
City
Region
Status
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
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.
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