Status:
RECRUITING
Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to find a new radioimmunotherapy regimen for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The main questions it a...
Detailed Description
More effective treatment regimens remain to be explored for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The combination of radiotherapy and immunot...
Eligibility Criteria
Inclusion
- advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record;
- disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness;
- patients with disease progression or drug resistance after previous immunotherapy are allowed to be included; a history of radiotherapy in the LDRT area or other sites is allowed to be included, provided that there are no residual toxic effects;
- at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured;
- no contraindications to radiotherapy;
- Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy \>3 months;
- important organ function is acceptable, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, glutamic pyruvic transaminase and glutamic oxalacetic transaminase ≤2.5 times the upper limit of normal value, serum creatinine \< 178μmol/L;
- voluntary participation and sign the informed consent.
Exclusion
- no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met;
- permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions;
- serious cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, serious and uncontrolled systemic infections or other contraindications, or any contraindications to radiotherapy, and some comorbidities should be re-evaluated after symptomatic treatment;
- any active immune system disease or related history;
- systemic immunosuppressive drugs are expected to be used during the study;
- a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance;
- other important medical or physiological conditions (such as pregnancy or breastfeeding status);
- patients who are known to be allergic to the drugs used in this study;
- patients refuse or are unable to sign the informed consent.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06173219
Start Date
August 1 2025
End Date
December 31 2026
Last Update
February 27 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100853