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RECRUITING
NCT07801287
PHASE2

Iparomlimab/Tuvonralimab Plus SBRT and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage HCC

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (the combination antibody) combined with SBRT and Lenvatinib in the perioperative treatment of patients with potentially resectable intermediate-stage hepatocellular carcinoma.. The objective is to explore potential survival benefits for this population and provide patients with more effective treatment options.

Official title: A Single-Arm, Single-Center Clinical Trial Evaluating Efficacy and Safety of Iparomlimab/Tuvonralimab Plus Stereotactic Body Radiation Therapy and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-01

Completion Date

2028-08-15

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Iparomlimab/Tuvonralimab plus SBRT and Lenvatinib

Iparomlimab/Tuvonralimab: Intravenous infusion of 7.5 mg/kg repeated every 21 days as one cycle. Administration for 2-3 cycles before sugery and continuously for one year after surgery. Lenvatinib: orally at a dose of 8 mg once daily (for patients with body weight \<60 kg) or 12 mg once daily (for patients with body weight ≥60 kg), and taken continuously for one year after surgery. Stereotactic body radiation therapy: 40-45 Gy/5F, once daily, 1-2 weeks before Iparomlimab/Tuvonralimab. Surgery will be performed within 4-6 weeks after the last dose of conversion therapy, with a maximum of 12 weeks.

Locations (1)

Tianjin medical university institute & hospital

Tianjin, China