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Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma
Sponsor: West China Hospital
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
Conditions
Interventions
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.
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