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NCT05367687 | Active, not recruiting | Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation


A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:

A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.

Condition or disease

Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Intervention/treatment

Camrelizumab、Rivoceranib

Camrelizumab

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 251 participants
Masking: None (Open Label)
Masking Description: Camrelizumab Plus Rivoceranib (Apatinib) compared with Camrelizumab
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multi-Center, Phase 2 Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : April 30, 2026
Arm Intervention/treatment

Experimental: Treatment group

Camrelizumab Plus Rivoceranib (Apatinib)

Drug: Camrelizumab、Rivoceranib

Active Comparator: Control group

Camrelizumab

Drug: Camrelizumab

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
  • 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.
  • Previous or current presence of metastasis to central nervous system.

A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

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A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

China, Shanghai

Zhongshan Hospital, Fudan University

Shanghai, Shanghai, China, 200032

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