TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma

Sponsor
Guohui Xu
Study ID
NCT06485466
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TACE plus camrelizumab and apatinib — COMBINATION_PRODUCT
    TACE plus camrelizumab and apatinib group: Patients who were randomized to this group, TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Within 1 week after first TACE treatment, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
  • Camrelizumab and apatinib — COMBINATION_PRODUCT
    Camrelizumab and apatinib group: Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Study Details

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC. The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC. This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.

Key Dates

Start date
Aug 10, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
101 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TACE plus camrelizumab and apatinib
    Procedure: TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
  • Active Comparator: Camrelizumab plus apatinib
    Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Primary Outcome Measure

progression free survival (PFS) [ Time Frame: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Central Contacts

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