An interventional study of Curative-Intent Liver Resection and Immunotherapy-Based Systemic Maintenance Therapy in Hepatocellular Carcinoma, sponsored by West China Hospital. Not yet recruiting at 9 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by West China Hospital · Not applicable, Interventional, and Treatment
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.
Improved systemic and locoregional treatments for hepatocellular carcinoma (HCC) have enabled some patients to achieve a radiologic complete response (rCR). Nevertheless, rCR does not necessarily indicate a pathological complete response because viable tumor cells may remain despite the absence of visible active tumor on imaging. The optimal management of patients with confirmed rCR who are candidates for curative-intent liver resection remains uncertain. Surgical consolidation may remove residual viable tumor and provide pathological information, but it also exposes patients to perioperative risks. Continuing systemic maintenance therapy may avoid unnecessary surgery but may leave clinically undetectable residual disease.
SWITCH-R is a multicenter, prospective, open-label, randomized, exploratory study comparing surgical resection with systemic maintenance therapy in patients with HCC who achieve and maintain rCR after anticancer treatment. The treatment leading to rCR must include a programmed cell death protein 1 or programmed death-ligand 1 (PD-1/PD-L1) inhibitor combined with a targeted or anti-angiogenic agent and may also include locoregional treatment, such as transarterial chemoembolization, hepatic arterial infusion chemotherapy, radiotherapy, or ablation.
After the first documentation of rCR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST), patients continue their original systemic treatment and undergo confirmatory imaging using the same imaging method 4 to 8 weeks later. Patients with sustained rCR, no evidence of extrahepatic or other active HCC, and a multidisciplinary team assessment indicating that curative R0 liver resection is feasible are eligible for randomization.
Approximately 60 participants will be randomly assigned in a 1:1 ratio to the surgical resection group or the maintenance therapy group. Randomization will be stratified according to tumor resectability before the treatment that resulted in rCR (resectable versus unresectable). Because the two strategies are visibly different, participants and treating investigators will not be masked to treatment assignment.
Participants assigned to the surgical resection group will undergo curative-intent liver resection after an appropriate washout period based on their previous systemic treatment. Resected tissue will be assessed for margin status, pathological complete response, major pathological response, the proportion of residual viable tumor, microvascular invasion, and other pathological characteristics. Participants who recover adequately will resume their pre-randomization systemic treatment approximately 4 to 8 weeks after surgery.
Participants assigned to the maintenance therapy group will continue the same PD-1/PD-L1 inhibitor plus targeted or anti-angiogenic treatment they were receiving before randomization. Dose modifications and temporary treatment interruptions are permitted for treatment-related toxicity, but changing therapy for reasons other than disease progression is not planned.
In both groups, systemic treatment will continue until disease recurrence or progression, unacceptable toxicity, death, or fulfillment of the study-defined drug-off criteria. Systemic treatment may be stopped after all of the following conditions have been maintained for at least 24 weeks: no radiologic evidence of recurrence or metastasis after surgery in the surgical group, or continued mRECIST rCR in the maintenance group; no new tumor lesions; normalization and sustained stability of any tumor markers that were elevated before treatment, including alpha-fetoprotein or protein induced by vitamin K absence-II; and no other clinical evidence of active tumor. The decision to stop treatment will be made by a multidisciplinary team. Participants who stop treatment will remain in imaging, patient-reported outcome, and survival follow-up.
Tumor imaging will include contrast-enhanced computed tomography and/or magnetic resonance imaging of the chest, abdomen, and pelvis. Assessments are planned every 9 weeks through week 36 after randomization and every 12 weeks thereafter. Disease recurrence or progression will primarily be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), with mRECIST used as a supplementary assessment. Imaging will undergo blinded independent central review.
The primary endpoint is time to treatment failure as assessed by independent radiologic review, defined in this protocol as the time from randomization to the first occurrence of disease recurrence or progression according to RECIST v1.1 or death from any cause. Secondary and exploratory evaluations include overall survival, investigator- and mRECIST-assessed time to treatment failure, treatment discontinuation under the drug-off criteria, time to drug-off, drug-free survival, safety, surgical outcomes, patient-reported quality of life, pathological response, circulating tumor DNA, and tumor-marker dynamics.
The study uses a randomized Pick-the-Winner screening design. The planned sample size of 60 participants, with 30 participants in each group, is based on the exploratory purpose of the study and the feasibility of recruiting this selected patient population rather than on a formal superiority or noninferiority hypothesis. Treatment effects will therefore be described primarily using estimates and 95% confidence intervals to inform the design of a future confirmatory study.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →West China Hospital is the lead sponsor of 484 studies on the registry; 241 are open to participants now.
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Exclusion Criteria:
Participants will undergo curative-intent liver resection after an appropriate washout period based on the systemic anticancer treatment received before randomization. The surgical goal is R0 resection. Participants who recover adequately will resume their pre-randomization systemic treatment, consisting of a PD-1/PD-L1 inhibitor combined with a targeted or anti-angiogenic agent, approximately 4 to 8 weeks after surgery. Treatment may continue until disease recurrence or progression, unacceptable toxicity, death, or fulfillment of the protocol-defined drug-off criteria.
Procedure: Curative-Intent Liver Resection · Procedure: Immunotherapy-Based Systemic Maintenance Therapy
Participants will continue the same systemic anticancer treatment received before randomization, consisting of a PD-1/PD-L1 inhibitor combined with a targeted or anti-angiogenic agent. Dose modifications and temporary treatment interruptions are permitted for treatment-related toxicity. In the absence of disease progression, changing the anticancer regimen for lack of efficacy is not planned. Treatment may continue until disease recurrence or progression, unacceptable toxicity, death, or fulfillment of the protocol-defined drug-off criteria.
Procedure: Immunotherapy-Based Systemic Maintenance Therapy
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.
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.
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).
Time frame: From randomization to disease recurrence or progression or death from any cause, assessed up to approximately 48 months
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 frame: From randomization to death from any cause, assessed up to approximately 48 months
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 frame: From randomization to disease recurrence or progression or death from any cause, assessed up to approximately 48 months
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 frame: From randomization to disease recurrence or progression or death from any cause, assessed up to approximately 48 months
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).
Time frame: From randomization to disease recurrence or progression or death from any cause, assessed up to approximately 48 months
Drug-Off Rate
The drug-off rate is the proportion of randomized participants who meet all protocol-defined drug-off criteria for at least 24 weeks and discontinue systemic anticancer treatment after multidisciplinary team assessment. The criteria include sustained absence of active or new tumor, normalization and sustained stability of tumor markers that were elevated before treatment, and no other clinical evidence of active tumor.
Time frame: From randomization through study completion, assessed up to approximately 48 months
Time to Drug-Off
Time to drug-off is defined as the time from randomization to the date on which a participant first meets the protocol-defined drug-off criteria and discontinues systemic anticancer treatment after multidisciplinary team assessment.
Time frame: From randomization to discontinuation of systemic treatment under the drug-off criteria, assessed up to approximately 48 months
Drug-Free Survival
Drug-free survival is defined for participants who discontinue systemic anticancer treatment after meeting the protocol-defined drug-off criteria. It is measured from the date systemic treatment is stopped to the first occurrence of disease recurrence or progression, restart of anticancer treatment, or death from any cause, whichever occurs first.
Time frame: From protocol-defined drug-off to disease recurrence or progression, restart of anticancer treatment, or death, assessed up to approximately 48 months
Incidence and Severity of Adverse Events
The number and percentage of participants experiencing adverse events and serious adverse events will be summarized by treatment group. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). The relationship of each event to systemic treatment, surgery, and study procedures will also be assessed.
Time frame: From randomization through 30 days after the last study treatment or surgery, or until new anticancer treatment, assessed up to approximately 48 months
Incidence and Severity of Surgical Complications
Among participants assigned to the surgical resection group who undergo liver resection, surgical complications, including bleeding, bile leakage, liver failure, infection, and wound complications, will be recorded and graded according to the Clavien-Dindo classification.
Time frame: From surgery through postoperative safety follow-up, approximately 30 days after surgery
Change From Baseline in EORTC QLQ-C30 Scores
Health-related quality of life will be assessed using the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale and single-item scores are transformed to a range of 0 to 100. Higher scores on functional and global health status scales indicate better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden. Scores and changes from baseline will be compared between treatment groups over time.
Time frame: Baseline; weeks 9, 18, 27, and 36; then every 12 weeks until recurrence or progression, withdrawal, or study completion, up to approximately 48 months
Change From Baseline in EORTC QLQ-HCC18 Scores
Hepatocellular carcinoma-specific symptoms and quality-of-life concerns will be assessed using the 18-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 module (EORTC QLQ-HCC18). Domain and single-item scores are transformed to a range of 0 to 100, with higher scores indicating more severe symptoms or problems. Scores and changes from baseline will be compared between treatment groups over time.
Time frame: Baseline; weeks 9, 18, 27, and 36; then every 12 weeks until recurrence or progression, withdrawal, or study completion, up to approximately 48 months
Plan to share: Yes — De-identified individual participant data that support the results reported in study publications may be shared with qualified researchers upon reasonable request to the principal investigator.
Supporting information: Study protocol
No publications or documents are linked to this record.
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