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 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SHR-1210-III-325
• Study Type: interventional
• Target: 687
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)

  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).

  Randomization up to approximately 43 months

Secondary Outcomes (4)

• RFS Rate at 24 and 36 Months, as Assessed by the Investigator

  Randomization up to 24 months and up to 36 months

• Time to Recurrence (TTR) as determined by the investigator and by BIRC

  Randomization up to approximately 43 months

• Overall Survival (OS)

  Randomization up to approximately 43 months

• The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0

  Baseline up to approximately 43 months

Study Arms (2)

Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))

EXPERIMENTAL

Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)

Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)

Control group (Active surveillance)

NO INTERVENTION

Interventions

Camrelizumab DRUG

Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder

Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))

Rivoceranib (Apatinib) DRUG

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

Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (6)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanjin, Guangzhou, China

Location

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (6)