Surgery vs. Watch-and-Wait Strategy in Partial & Complete Responders for Hepatocellular Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Surgical Resection: Patients in the Surgical Resection (SR) cohort should undergo curative resection within 1-2 weeks after the index date. Perioperative medication management shall be conducted in accordance with the participating center's standards, and unified pathological assessments shall be performed for pathological complete response (pCR), major pathological response (MPR), and surgical margin status. Adjuvant therapy shall be initiated 4-8 weeks postoperatively, using the same preoperative PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) regimen, and continued until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria. \[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.\]
Maintenance Therapy Group: Patients in the Maintenance Therapy (MT) cohort shall continue treatment with PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) starting from the index date, until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria. \[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.\]
Study summary
The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.
Eligibility
Primary outcome measure(s)
- Time to Treatment Failure (TTF) per RECIST v1.1 — From date of enrollment until treatment failure, assessed up to 36 months
TTF is defined as the time from the date of enrollment to the date of first documented treatment failure, including local recurrence, intrahepatic progression, extrahepatic spread (EHS), or death from any cause. Tumor assessment is performed using CT or MRI evaluated by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | China | Recruiting |
More West China Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07410715 on ClinicalTrials.gov ↗ ← All trials in China