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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Start date: Apr 28, 2025 to Jun 20, 2025v2 Show 6 more changesShow less
    • Primary completion date: Apr 27, 2028 to Jun 19, 2028
    • Study completion date: Apr 27, 2029 to Jun 19, 2029
    • Interventions: Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventionally Fractionated Radiotherapy Combined with… to Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with…
    • Eligibility criteria revised
    • Study title revised
    • Study description expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06936748
Lead Sponsor Second Affiliated Hospital of Nanchang University
Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Cancer
Related terms Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov