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Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Study acronym: CCGLC-017
StatusRecruiting
PhasePhase 2
Started2025-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-19
notable
Recruitment opened
2025-06-10
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Start date2025-06-15→2025-08-01
Enrollment target27→26
InterventionsIparomlimab and Tuvonralimab (QL1706) (Drug), Partial hepatectomy (Procedure), TACE (Procedure)→Iparomlimab and Tuvonralimab (QL1706) (Drug), Partial hepatectomy (Procedure)
Eligibility criteria-45 characters
[...] e criteria for resectable HCC with High Risk of Recurrence: Tumor diameter >5cm or multipleMultiple (≥32) tumors. Segmental portal vein invasion (Vp1/Vp2). CT/MRI imaging: gross classification: infiltrativetype typeII, typeIII, ⅣIV. AFP>400μg/L. Estimated life expectancy of ≥12 weeks. Female subjects of c [...]
Secondary endpointsdetails revised at 1 of 10 entries
Study description-51 characters
[...] y. This study primarily evaluates the impact of iparomlimab combined withand tuvonralimab (QL1706) as preoperative neoadjuvant therapy on recurrence-free surv [...] Enrolled patients will receive a single dose of iparomlimab/ and tuvonralimab within one week prior to surgery, followed by one session of transarterial chemoembolization (TACE) and six cycles of iparomlimab/ and tuvonralimab therapy postoperatively.
2025-04-23
minor
Original filing
197 trials monitored
See 2 trials at risk
1,505 trials monitored
See 60 trials at risk
The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.
Trial Details
NCT Number NCT06954116
Lead Sponsor Tongji Hospital
Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions Resectable Hepatocellular Carcinoma With High Risk of Recurrence
Enrollment 26 participants
Start Date 2025-08-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-18