A Study to Evaluate Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Surgical Resection or Ablation

Overview

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

Full Title of Study: “A Randomized, Open-Label, Multi-Center, Phase 3 Clinical Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Surgical Resection or Ablation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2024

Interventions

  • Drug: Camrelizumab
    • Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
  • Drug: Apatinib
    • Subjects receive Apatinib orally, Dosage form: tablet

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • RFS Rate at 24 and 36 Months, as Assessed by the Investigator
    • Time Frame: Randomization up to 24 months and up to 36 months
  • Time to Recurrence (TTR) as determined by the investigator and by BIRC
    • Time Frame: Randomization up to approximately 43 months
    • TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC
  • Overall Survival (OS)
    • Time Frame: Randomization up to approximately 43 months
    • OS is defined as the time from randomization to death from any cause
  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
    • Time Frame: Baseline up to approximately 43 months

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects with a clinical or 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 surgical resection or ablation – Absence of major macrovascular invasion – No extrahepatic spread – Full recovery from surgical 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 – Recurrent HCC prior to randomization – Evidence of residual, recurrent, or metastatic disease 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 – Co-infection with HBV and HCV – 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 surgical procedure within four weeks – Factors to affect oral administration – Previous or current presence of metastasis to central nervous system
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Jiangsu HengRui Medicine Co., Ltd.
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Contact(s)
      • Linna Wang, MD, 021-60453196, wanglinna@hrglobe.cn

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