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NCT Number: NCT06363773

A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.

This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (> 6 months) and displaying disease progression.

In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.

The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Clinical

Soyaux, Charente, 16800, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient having received previous radiotherapy since the start of immunotherapy,
  • Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
  • 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,
  • Patient with hematological cancer,
  • Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
  • Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
  • Pregnant or breast-feeding women,
  • Patient under legal protection.

Treatment and study plan

Stereotactic radiotherapy

Radiation

Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between.

Patients enrolled in the study would not have received this stereotactic radiotherapy outside the study, that is why this procedure is additional (compared to Standard of care) and considered as burdensome (as this is radiation). Before performing the stereotactic radiotherapy, patients will do a radiotherapy CT scanner (no injected) in order to prepare precisely the radiotherapy (treatment plan).

Primary outcomes

  1. Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

    Time frame: At 3 months after stereotactic radiotherapy

    Assessment of Objective Response Rate (Complete Response and Partial Response with iRECIST criteria) according to a centralised independent reading.

Secondary outcomes

  1. Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy.

    Time frame: At 3 months after stereotactic radiotherapy

    Assessment of Objective Response Rate (Complete Response and Partial Response with RECIST 1.1 criteria) according to a centralised independent reading.

  2. Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

    Time frame: Up to 12 months after stereotactic radiotherapy

  3. Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

    Time frame: Up to 12 months after stereotactic radiotherapy

  4. Duration until new systemic treatment start.

    Time frame: Up to 12 months after stereotactic radiotherapy

    Duration (in days) before introduction of a new systemic treatment.

  5. Incidence of Adverse Events (safety)

    Time frame: Up to 12 months after stereotactic radiotherapy

    Collection of adverse events (AEs) up to 12 months after radiotherapy.

  6. Progression-Free Survival

    Time frame: Up to 12 months after stereotactic radiotherapy

  7. Overall Survival

    Time frame: Up to 12 months after stereotactic radiotherapy

  8. Objective Response Rate according to iRECIST criteria on the irradiated lesion only.

    Time frame: Up to 12 months after stereotactic radiotherapy

  9. Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only.

    Time frame: Up to 12 months after stereotactic radiotherapy

  10. Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect).

    Time frame: Up to 12 months after stereotactic radiotherapy

  11. Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect).

    Time frame: Up to 12 months after stereotactic radiotherapy

  12. Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect).

    Time frame: Up to 12 months after stereotactic radiotherapy

  13. Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect).

    Time frame: Up to 12 months after stereotactic radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent ATALLAH, Dr

CONTACT

[email protected]

05 45 69 68 32 ext. +33

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Pilot, Exploratory, Prospective Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Anti-PD1 Immunotherapy in Initially Long-responder Patients With Metastatic Progression.

Acronym: RESTO-IMMUNO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 12, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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