Combining radiotherapy and immunotherapy for advanced cancer treatment

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.

This study is testing a new treatment that combines radiation and immune therapy for patients with advanced cancer that hasn't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06173219 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced malignant solid tumors that have multiple metastases and have experienced disease progression after standard treatments.

Not a fit: Patients who have contraindications to radiotherapy or those with an ECOG score greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Previous studies have shown promising results with similar combinations of radiotherapy and immunotherapy, indicating potential for success in this approach.

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 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 this trial is running

Beijing, Beijing Municipality

• 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.

Conditions Advanced Solid Tumor; advanced solid tumor; standard treatment failure; radiotherapy; immunotherapy