Surgery vs. Watch-and-Wait Strategy in Partial & Complete Responders for Hepatocellular Carcinoma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with hepatocellular carcinoma (HCC) who achieve complete response (CR) or partial response (PR) following conversion therapy and are deemed eligible for radical hepatectomy (R0 resection) by the multidisciplinary team (MDT) at participating centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical Resection
Other interventionPatients 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
Other interventionPatients 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. \[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.\]
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Surgical Resection (SR) cohort1 intervention
Group B: Maintenance Therapy (MT) cohort1 intervention
Trial outcomes
Primary outcomes
1
Time to Treatment Failure (TTF) per RECIST v1.1
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.
Time frame
From date of enrollment until treatment failure, assessed up to 36 monthsSecondary outcomes
1
Time to Treatment Failure (TTF) per mRECIST
TTF assessed by IRF and investigators according to modified RECIST (mRECIST) for Hepatocellular Carcinoma. Defined as time from date of enrollment to treatment failure (recurrence, progression, or death).
Time frame
From date of enrollment until treatment failure, assessed up to 36 months2
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death due to any cause. For patients still alive at the time of analysis, the data will be censored at the last date the patient was known to be alive.
Time frame
From date of enrollment until death, assessed up to 36 months3
12-month Overall Survival (OS) Rate
The proportion of participants who are alive at 12 months after the date of enrollment.
Time frame
At 12 months post-enrollment4
Pattern of Recurrence or Progression
Characterization of the first failure event classified by site: Intrahepatic (local recurrence vs. new lesion) or Extrahepatic (distant metastasis). Confirmation involves radiographic evaluation (CT/MRI) and, where feasible, histological/cytological confirmation. Categorized as solitary vs. multiple lesions and resectable vs. unresectable.
Time frame
From date of enrollment until first recurrence/progression, assessed up to 36 monthsOther outcomes
1
R0 Resection Rate
The percentage of enrolled participants undergoing surgery who achieve R0 resection. R0 resection is defined as the complete removal of all macroscopic tumor with microscopically negative surgical margins (no tumor cells at the cut edge), confirmed by postoperative histopathological report.
Time frame
At the time of surgery (Day 0) up to 30 days after surgery2
Pathological Response Rate (pathological complete response and major pathological response)
Assessed by histological examination of the resected tumor specimen. Pathological Complete Response (pCR) is defined as no viable tumor cells. Major Pathological Response (MPR) is defined as viable tumor cells ≤50%.
Time frame
Up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov