Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence
NCT06954116 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-06-13
Summary
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.
Conditions
- Resectable Hepatocellular Carcinoma With High Risk of Recurrence
Interventions
- DRUG
-
Iparomlimab and Tuvonralimab (QL1706)
Neoadjuvant phase: A single cycle of Iparomlimab and Tuvonralimab (7.5 mg/kg) will be administered within 1 week prior to surgery. Adjuvant phase: Six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be initiated starting at 2 weeks postoperatively.
- PROCEDURE
-
Partial hepatectomy
Will be performed at an appropriate interval following neoadjuvant therapy initiation.
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Tongji Hospital
lead OTHER
Principal Investigators
-
Ze-yang Ding, M.D. · Tongji Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-04-01
Countries
- China
Study Locations
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