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RecruitingPhase 3NCT06485466

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

Sponsor

Guohui Xu

Enrollment

101 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

Unresectable Hepatocellular CarcinomaApatinibCamrelizumabTransarterial Chemoembolization

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments — TACE (a procedure that delivers chemotherapy directly to liver tumors while cutting off their blood supply), camrelizumab (an immunotherapy), and apatinib (a targeted drug) — as a first treatment for liver cancer that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with hepatocellular carcinoma (primary liver cancer), confirmed by pathology or clinical criteria - You have not received any prior treatment for liver cancer - You have at least one measurable liver tumor - Your liver is functioning adequately (Child-Pugh score of 7 or less) - You have a life expectancy of at least 12 weeks - Your cancer is classified as BCLC stage B or C (intermediate or advanced) **You may NOT be eligible if...** - You have previously been treated for liver cancer - You have other types of liver cancer (e.g., cholangiocarcinoma) - You have a history of liver transplant or liver encephalopathy - You have significant fluid buildup in your chest or abdomen requiring drainage - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTACE 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_PRODUCTCamrelizumab 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.

Locations(1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

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NCT06485466

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