Using targeted stereotactic radiotherapy to try to restore immunotherapy response in metastatic cancer

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

The trial enrolls adults with metastatic solid tumors who have been on anti‑PD‑1 immunotherapy for six months or more but now show disease progression by iRECIST/RECIST 1.1. Participants receive stereotactic radiotherapy to one target lesion given as three 8 Gy fractions spaced 72 hours apart while continuing standard‑of‑care immunotherapy. The main goal is to see whether local high‑dose radiotherapy can trigger an abscopal effect, producing tumor regression at non‑irradiated metastatic sites. The radiotherapy devices are used according to their CE mark and institutional practice, and outcomes are measured on measurable lesions per RECIST/iRECIST criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, 18 years of age or older,
2. Patient with a metastatic solid tumor,
3. Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
4. Measurable disease according to RECIST 1.1 and iRECIST criteria,
5. Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
6. Disease progression with immunotherapy (progression assessed by iRECIST criteria) but having received at least 6 months of immunotherapy,
7. Performance Status (PS) of 0 or 1,
8. Patient eligible for stereotactic radiotherapy,
9. Patient affiliated to or benefiting from a social security scheme,
10. Patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures,
11. Patient willing and able to undergo all examinations and procedures in accordance with the clinical investigation plan.

Exclusion Criteria:

1. Patient having received previous radiotherapy since the start of immunotherapy,
2. Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
3. Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment,
4. Patient with hematological cancer,
5. Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
6. Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
7. Pregnant or breast-feeding women,
8. Patient under legal protection.

Where it's running

• Centre Clinical
  Soyaux, Charente, France Recruiting

Study contacts

• Study coordinator: Vincent ATALLAH, Dr
• Email: vincentatallah298@hotmail.com
• Phone: 05 45 69 68 32

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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.