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Recruiting Phase 1, Phase 2 NCT06173219

Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.

Trial Parameters

Condition Advanced Solid Tumor
Sponsor China-Japan Friendship Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 38
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-08-01
Completion 2026-07-31
Interventions
Radiotherapy combined with immunotherapy

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 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.

Eligibility Criteria

Inclusion Criteria: 1. advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record; 2. disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness; 3. 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; 4. at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured; 5. no contraindications to radiotherapy; 6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy \>3 months; 7. 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

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