MedTrace Logo

TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma

NCT06485466 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

COMBINATION_PRODUCT

TACE plus camrelizumab and apatinib

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.

COMBINATION_PRODUCT

Camrelizumab and apatinib

Camrelizumab and apatinib group: Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Sponsors & Collaborators

  • Guohui Xu

    lead OTHER

Principal Investigators

  • Guohui Xu · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-10
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485466 on ClinicalTrials.gov