NCT06485466

TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma

Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Guohui Xu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Unresectable Hepatocellular Carcinoma
• Transarterial Chemoembolization
• Camrelizumab
• Apatinib

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-10
• Primary completion: 2026-06-30
• Completion: 2028-06-30
• First posted: 2024-07-03
• Last updated: 2026-04-14

Locations

1 site across 1 country: China