Actively Recruiting
Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
Led by China-Japan Friendship Hospital · Updated on 2025-02-27
38
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 aims to answer is: the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function. Participants will receive the combination of radiotherapy and immunotherapy.
CONDITIONS
Official Title
Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced malignant solid tumors with multiple metastases or relapses confirmed by pathology or medical records
- Disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or refusal of standard treatment
- Patients with progression or drug resistance after previous immunotherapy allowed
- History of radiotherapy allowed if no residual toxic effects
- At least one lesion suitable for stereotactic body radiotherapy (SBRT) and one lesion suitable for low-dose radiotherapy (LDRT) that can be measured
- No contraindications to radiotherapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 and life expectancy greater than 3 months
- Acceptable organ function including white blood cells ≥3.0x10^9/L, platelets ≥75x10^9/L, hemoglobin ≥90 g/L, liver enzymes ≤2.5 times upper limit of normal, serum creatinine <178 µmol/L
- Voluntary participation with signed informed consent
You will not qualify if you...
- No suitable lesions for radiotherapy or inability to meet important organ risk limits
- Permanent discontinuation of PD-1/PD-L1 inhibitors due to grade 3 or higher immune-related toxic reactions
- Serious cardiovascular or cerebrovascular disease, severe liver or kidney dysfunction, uncontrolled infections, or other contraindications to radiotherapy
- Active immune system diseases or relevant history
- Expected use of systemic immunosuppressive drugs during the study
- History of severe uncontrollable central nervous system diseases or mental disorders affecting consent or compliance
- Pregnancy or breastfeeding
- Known allergy to study drugs
- Refusal or inability to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
G
Guangying Zhu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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