Clinical trial · Interventional
Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
A Prospective Clinical Trial Evaluating the Safety and Efficacy of Radiotherapy Combined with Immunotherapy in Advanced Refractory Solid Malignancies After Standard Treatment Failure/drug Resistance.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy combined with immunotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- The subjects will receive the combination therapy of SBRT, LDRT, PD-1/L1 inhibitor and GMCSF. The specific treatment regimen is as follows: (1) SBRT 8Gy×3f, (2) LDRT 2Gy ×3f, PD-1/L1 inhibitor, periodically, until the disease progresses or intolerable toxic side effects, (4) GM-CSF, 200ug/QD, subcutaneous injection, the first course of treatment for 7 days.
- interventionNames
- Combination Product: Radiotherapy combined with immunotherapy
Primary outcomes (1)
- measure
- Adverse event rate
- timeFrame
- 6 weeks
- description
- The proportion of treatment-related toxicities cases to the total evaluable cases, assessed according to CTCAE 5.0 criteria.
Secondary outcomes (2)
- measure
- Objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 transaminase ≤2.5 times the upper limit of normal value, serum creatinine \< 178μmol/L; 8. voluntary participation and sign the informed consent. Exclusion Criteria: 1. no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met; 2. permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions; 3. 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; 4. any active immune system disease or related history; 5. systemic immunosuppressive drugs are expected to be used during the study; 6. a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance; 7. other important medical or physiological conditions (such as pregnancy or breastfeeding status); 8. patients who are known to be allergic to the drugs used in this study; 9. patients refuse or are unable to sign the informed consent.
References
Publications (0)
Data not yet available