SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Re… (NCT06936748) | Clinical Trial Compass
RecruitingPhase 2
SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors
China30 participantsStarted 2025-06-20
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. ECOG: 0-2 points.
✓. Expected survival ≥3 months.
✓. Washout period of previous anti-tumor treatment \>4 weeks.
✓. The patient agrees and signs the informed consent form.
Exclusion criteria
✕. 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.
What they're measuring
1
Safety (treatment-related toxicity and adverse reactions)
Timeframe: The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 1 year after end of treatment
Trial details
NCT IDNCT06936748
SponsorSecond Affiliated Hospital of Nanchang University
✕. History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
✕. Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can proceed to further screening:
✕. Controlled Type 1 diabetes
✕. Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
✕. Skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia)
✕. Any other condition not expected to recur without external triggering factors