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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Resection (SR) cohort |
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| Maintenance Therapy (MT) cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Resection | Other | 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.] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of enrollment until treatment failure, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From date of enrollment until treatment failure, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of surgery (Day 0) up to 30 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kunlin Xie, MD/PhD | Contact | +86 18980607259 | xiekun@scu.edu.cn |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Maintenance Therapy Group | Other | 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.] |
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| 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. |
| From date of enrollment until death, assessed up to 36 months |
| 12-month Overall Survival (OS) Rate | The proportion of participants who are alive at 12 months after the date of enrollment. | At 12 months post-enrollment |
| 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. | From date of enrollment until first recurrence/progression, assessed up to 36 months |
| Incidence of Adverse Events (AEs) | Percentage of participants experiencing treatment-emergent adverse events. AEs are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for systemic therapy, and surgical complications are graded according to the Clavien-Dindo Classification and comprehensive complication index (CCI). | From date of enrollment through 90 days after the last dose of study treatment or surgery |
| 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%. | Up to 30 days after surgery |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |