NCT07410715

Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma (SWITCH)

Surgery Versus Maintenance After Conversion-therapy-Achieved Complete/Partial Response in Hepatocellular Carcinoma: a Prospective Multicenter Non-randomized Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC - Hepatocellular Carcinoma
• Watch & Wait
• Surgery

Interventions

Type	Name	Description
OTHER	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. \[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.\]
OTHER	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. \[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.\]

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-02-13
• Last updated: 2026-02-13