Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma (SWITCH)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWest China Hospital
About this trial
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 criteria
Qualifiers
Aged 18-80 years.
Diagnosed with locally advanced, metastatic, and/or initially unresectable hepatocellular carcinoma (uHCC) via histology/cytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients).
Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.1.
Completed conversion therapy [systemic therapy (PD-1/PD-L1 ± TKI) ± local therapy (TACE/HAIC/radiation/ablation, etc.)], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later.
Disqualifiers
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC.
Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and/or MRI.
Inability to achieve R0 resection.
Previous liver transplantation or on the liver transplantation waiting list.
Trial design
Treatments tested in this trial
- Surgical Resection
- Maintenance Therapy Group
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov