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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04639180
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
  • Rivoceranib (Apatinib) — DRUG
    Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
687 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))
    Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)
  • No Intervention: Control group (Active surveillance)

Primary Outcome Measure

Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) [ Time Frame: Randomization up to approximately 43 months ]

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