Combining radiotherapy and immunotherapy for advanced cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate a new treatment regimen that combines radiotherapy with immunotherapy for patients with advanced malignant solid tumors that have not responded to standard treatments. The study will assess the safety and efficacy of this combination, focusing on patients with multiple metastatic disease and exploring its impact on immune function. Participants will receive stereotactic radiotherapy (SBRT), low-dose radiotherapy (LDRT), and PD-1/PD-L1 inhibitors along with GM-CSF. The goal is to find a more effective treatment option for those who have experienced treatment failure or drug resistance.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Guangying Zhu, M.D. — China-Japan Friendship Hospital
• Study coordinator: Guangying Zhu, M.D.
• Email: zryyfa@163.com
• Phone: +86-010 84205381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.