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).
Age 18-75 years, male or female.
Histologically confirmed malignant tumor in the past.
Disease recurrence after treatment, including local regional relapsed and distant metastasis.
At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.
History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
Any of the following conditions within 6 months prior to screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. Patients known to have coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on an optimized stable medical regimen as determined by the treating physician; consultation with a cardiologist may be appropriate if necessary.
History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
Controlled Type 1 diabetes
Second Affiliated Hospital of Nanchang University
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator