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NOT YET RECRUITING
NCT07866612
NA

Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. Some people with HCC have no visible active tumor on imaging after receiving anticancer treatment. This is called a radiologic complete response (rCR). However, imaging cannot always show whether small amounts of living cancer remain. It is not known whether these patients benefit more from surgery to remove the original tumor area or from continuing their current drug treatment without surgery. The purpose of this study is to compare two treatment strategies for adults with HCC who have a confirmed rCR and are considered able to undergo surgery intended to completely remove the tumor. About 60 participants will be randomly assigned in equal numbers to one of two groups. Participants in the surgical resection group will undergo liver surgery and, if they recover adequately, restart the same systemic anticancer treatment they were receiving before randomization approximately 4 to 8 weeks after surgery. Participants in the maintenance therapy group will continue the same systemic anticancer treatment without surgery. The systemic treatment consists of an immune checkpoint inhibitor combined with a targeted or anti-angiogenic drug. Participants in both groups may stop systemic anticancer treatment if they meet all study-defined stopping criteria for at least 24 weeks and a multidisciplinary medical team agrees that treatment can be stopped. Participants will continue to receive imaging examinations, laboratory tests, safety assessments, and quality-of-life assessments during and after treatment. The main study measure is the length of time from randomization until the cancer returns or worsens, or the participant dies from any cause. The study will also evaluate overall survival, side effects and surgical complications, the ability to stop treatment, survival without anticancer treatment, quality of life, findings from surgically removed tissue, and blood-based tumor markers.

Official title: Surgical Resection Versus Maintenance Therapy for Hepatocellular Carcinoma Patients Achieving Complete Radiologic Response After Antitumor Therapy: A Randomized Controlled Exploratory Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-12-01

Completion Date

2031-03-31

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

PROCEDURE

Curative-Intent Liver Resection

After an appropriate washout period based on the systemic anticancer agents received before randomization, participants will undergo curative-intent liver resection with the goal of achieving R0 resection. The surgical approach and extent of resection will be determined by the surgical team according to tumor location, liver function, future liver remnant, and the participant's overall condition. Resected tissue will be evaluated for margin status, pathological complete response, major pathological response, residual viable tumor, microvascular invasion, and other pathological features.

PROCEDURE

Immunotherapy-Based Systemic Maintenance Therapy

Participants will receive the same systemic anticancer regimen that produced the confirmed radiologic complete response before randomization. The regimen consists of a PD-1 or PD-L1 inhibitor combined with a targeted or anti-angiogenic agent. The specific agents, doses, and treatment schedules are participant-specific and are based on the pre-randomization regimen. Participants in the maintenance therapy group will continue treatment after randomization. Participants in the surgical resection group will resume treatment approximately 4 to 8 weeks after surgery if they have recovered adequately. Dose modification, temporary interruption, or discontinuation is permitted for treatment-related toxicity. Treatment may continue until disease recurrence or progression, unacceptable toxicity, death, or fulfillment of the protocol-defined drug-off criteria.

Locations (9)

Peking Union Medical College Hospital

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Provincial Hospital

Fuzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Jiangsu Province Hospital

Nanjing, China

Zhongshan Hospital, Fudan University

Shanghai, China