SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors
brief 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).
detailed description
1. Study Title A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined with Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors 2. Study Objectives Primary Objective: To evaluate the safety of SFRT followed by hypofractionated/Conventional Fractionated radiotherapy combined with Iparomlimab and Tuvonralimab 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. 3. Study Design Type: Prospective, single-arm, open-label, single-center clinical study. Target Population: Patients with relapsed/refractory bulky solid tumors (≥6 cm in diameter).
Sample Size: 30 participants (based on primary safety endpoint). 4. Patient Selection
Inclusion Criteria:
Age 18-75 years. Histologically confirmed malignancy with post-treatment recurrence (local or metastatic).
At least one measurable lesion (\>6 cm) unsuitable for surgery/ablation. ECOG performance status 0-2; life expectancy ≥3 months.
Adequate organ function (within 14 days prior to enrollment):
ANC ≥1.5×10⁹/L; platelets ≥90×10⁹/L; hemoglobin ≥8 g/dL. Serum albumin ≥2.8 g/dL; total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN with liver metastases).
Creatinine ≤1.5×ULN or CrCl ≥60 mL/min. INR/APTT ≤1.5×ULN (stable anticoagulation allowed). Negative pregnancy test (for women of childbearing potential). Willingness to comply with protocol and provide informed consent.
Exclusion Criteria:
Severe hypersensitivity to study drugs. History of cardiovascular events (e.g., myocardial infarction, stroke) within 6 months.
Active autoimmune disease (exceptions: controlled type 1 diabetes, hypothyroidism, localized skin conditions).
Immunodeficiency (e.g., HIV, organ transplant). Systemic corticosteroids (\>10 mg prednisone equivalent/day) within 2 weeks prior to treatment.
official title
A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined With Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors