Clinical Trial

SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors

Recruiting Phase 2
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Summary
Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors. Secondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes. Study Endpoints Primary: Safety (incidence/severity of treatment-related adverse events). Secondary: ORR, DCR, DoR, mPFS, mOS Exploratory: Biomarker analysis (PD-L1, IL-2, IL-10).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-17; most recent amendment 2026-04-29.
Status change: Not Yet Recruiting → Recruiting 2026-04-29
Trial Details
NCT Number NCT06936748
Lead Sponsor Second Affiliated Hospital of Nanchang University
Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions Cancer
Enrollment 30 participants
Start Date 2025-06-20
Primary Completion 2028-06-19 (estimated)
Study Completion 2029-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-05-05