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Single arm, prospective, open label clinical study on the application of low-dose radiotherapy combined with immunotherapy in multiple metastatic malignant tumors

Single arm, prospective, open label clinical study on the application of low-dose radiotherapy combined with immunotherapy in multiple metastatic malignant tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105070
Enrollment
Unknown
Registered
2025-06-27
Start date
2024-11-08
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple metastatic malignant tumors

Interventions

experimental group:Low dose radiotherapy combined with immunotherapy

Sponsors

The First Affiliated Hospital of Bengbu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Expected survival time>3 months 2. Multiple metastases throughout the body. 3. Surgical treatment or curative radiotherapy cannot be performed. 4. ECOG behavior status score 0-2 points; 5. All organ functions are basically normal (laboratory test results within one week before enrollment); Bone marrow function: Absolute neutrophil count (ANC) >= 1.5x109/L, platelet count >= 100x109/L, hemoglobin >= 9g/dL; Liver: serum total bilirubin = 60ml/min, urea nitrogen <= 200mg/L; Urinary protein<+, if urinary protein+, the total protein in 24 hours must be<500mg; Blood sugar: within the normal range and/or in the treatment of patients with diabetes, but the blood sugar is controlled at a stable state; Cardiac function: No myocardial infarction within 1 year; Unstable angina pectoris; Asymptomatic severe arrhythmia; Heartless dysfunction; 6. Have fully understood and voluntarily signed the informed consent form for this study;

Exclusion criteria

Exclusion criteria: 1. Brain metastasis; 2. Subjects with poor nutritional status or PG-SGA score >= 9; 3. The patient has any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.); 4. Have active infection or active tuberculosis history requiring systemic treatment; 5. Patients with the following active infectious diseases, including hepatitis triple positive, known human immunodeficiency virus (HIV) infection, active syphilis and other sexually transmitted diseases; 6. Severe allergy to any research treatment drug.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall survival;Adverse events that occurred during treatment;Local tumor control rate;Improvement of pain symptoms displayed on the pain rating scale;

Countries

China

Contacts

Public ContactHao jiang

The First Affiliated Hospital of Bengbu Medical College

Jianghao1223@163.com+86 135 0056 8891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026