RecruitingNCT06569498

Neoadjuvant Triple Therapy for Resectable HCC

Neoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical Trial


Sponsor

Fujian Provincial Hospital

Enrollment

20 participants

Start Date

Sep 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a triple combination treatment given before surgery for people with liver cancer (hepatocellular carcinoma, HCC) that could potentially be removed surgically. The treatment combines an anti-cancer drug, an immunotherapy drug, and a targeted therapy to try to shrink the tumor before surgery, making removal easier or possible. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (HCC) and have good liver function (Child-Pugh class A) - Your tumor is considered surgically resectable after specialist team review (BCLC stage A or B, single tumor over 5 cm or multiple tumors) - You have not received prior treatment for this cancer - Your blood counts and organ function are acceptable **You may NOT be eligible if:** - Your liver function is poor (Child-Pugh class B or worse) - Your cancer has spread outside the liver to distant organs - Your tumor cannot be measured on imaging - You have had previous liver surgery or organ transplant 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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Locations(6)

Fujian provincial hospital

Fuzhou, Fujian, China

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Zhongshan Hospital of Xiamen University

Xiamen, Fujian, China

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

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NCT06569498


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