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.
Voluntary participation and provision of written informed consent.
Age 18 to 80 years, inclusive.
HCC confirmed by histology or cytology or diagnosed according to accepted clinical diagnostic criteria. Histologic or cytologic confirmation is generally required for participants without cirrhosis.
No definite extrahepatic metastasis before initiation of the anticancer treatment that resulted in the current radiologic complete response (rCR).
Fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular-cholangiocarcinoma, or another atypical HCC histologic subtype.
Definite extrahepatic metastasis before initiation of the treatment that resulted in the current rCR, or any extrahepatic metastasis identified before randomization.
Inability to undergo safe curative liver resection, an expectation that R0 resection cannot be achieved, or another medical factor that prevents surgical consolidation.
Previous liver transplantation or current plans for liver transplantation.
Parallel
Curative-Intent Liver Resection
Procedure/SurgeryAfter 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
Procedure/SurgeryParticipants 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.
Time to Treatment Failure (TTF) as Assessed by Independent Review Facility
Time to treatment failure is defined as the time from randomization to the first occurrence of radiologically documented disease recurrence or progression or death from any cause, whichever occurs first. Disease recurrence or progression will be determined by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive. Overall survival rates at 12, 18, and 24 months will also be estimated.
Time to Treatment Failure Assessed by the Investigator Using RECIST v1.1
Time to treatment failure is defined as the time from randomization to the first occurrence of radiologically documented disease recurrence or progression or death from any cause, whichever occurs first. Disease recurrence or progression will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time to Treatment Failure Assessed by Independent Review Facility Using mRECIST
Time to treatment failure is defined as the time from randomization to the first occurrence of radiologically documented disease recurrence or progression or death from any cause, whichever occurs first. Disease recurrence or progression will be determined by blinded independent central review according to the modified Response Evaluation Criteria in Solid Tumors for hepatocellular carcinoma (mRECIST).
Time to Treatment Failure Assessed by the Investigator Using mRECIST
Time to treatment failure is defined as the time from randomization to the first occurrence of radiologically documented disease recurrence or progression or death from any cause, whichever occurs first. Disease recurrence or progression will be assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors for hepatocellular carcinoma (mRECIST).
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West China Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Fujian Provincial Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Peking Union Medical College Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
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