RecruitingPhase 2NCT06812039

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study


Sponsor

Fudan University

Enrollment

165 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of treatments given before and after surgery (perioperative) for liver cancer (hepatocellular carcinoma or HCC) that is operable but at high risk of coming back. The combination includes HAIC (a targeted chemotherapy delivered directly into the liver artery), donafenib (a targeted oral drug), and sintilimab (an immunotherapy drug). **You may be eligible if...** - You are 18–75 years old with confirmed liver cancer (HCC) that has not been treated before - Your cancer can be surgically removed with enough healthy liver remaining - You have at least one large tumor (over 5 cm), multiple tumors, or other high-risk features - You have good liver function (Child-Pugh class A) **You may NOT be eligible if...** - You have already received treatment for your liver cancer - Your liver function is too poor for surgery or the study drugs - Your cancer has spread beyond the liver to other organs or vessels - You have autoimmune conditions incompatible with immunotherapy 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

DRUGHAIC combined with sintilimab and donafenib

HAIC: Two cycles, Q3W. The chemotherapy regimen consists of oxaliplatin 85 mg/m² over 2 hours and raltitrexed 2 mg/m² over 1 hour. Donafenib: Treatment should begin the day after the completion of the first HAIC, with an initial dose of 0.1g bid p.o.. The investigator may increase the dose to 0.2g bid depending on the patient's condition. Sintilimab: Administration may begin after the first HAIC, 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles.

DRUGSintilimab and Donafenib

Donafenib: an initial dose of 0.1g bid p.o. The investigator may increase the dose to 0.2g bid depending on the patient's condition. Sintilimab: 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles.

PROCEDURESurgery

After surgery, received sintilimab and donafenib for 6 cycles.


Locations(3)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

TianJin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06812039


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