A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.
- Conditions
- Metastatic Cancer
- Interventions
- Radiation: Stereotactic Radiotherapy
- Registration Number
- NCT06363773
- Lead Sponsor
- Elsan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic radiotherapy Stereotactic Radiotherapy Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between, alongside anti-PD1 immunotherapy.
- Primary Outcome Measures
Name Time Method Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. 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 Outcome Measures
Name Time Method Overall Survival Up to 12 months after stereotactic radiotherapy Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy. 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.
Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. Up to 12 months after stereotactic radiotherapy 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. Up to 12 months after stereotactic radiotherapy Duration until new systemic treatment start. Up to 12 months after stereotactic radiotherapy Duration (in days) before introduction of a new systemic treatment.
Incidence of Adverse Events (safety) Up to 12 months after stereotactic radiotherapy Collection of adverse events (AEs) up to 12 months after radiotherapy.
Progression-Free Survival Up to 12 months after stereotactic radiotherapy Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only. Up to 12 months after stereotactic radiotherapy Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect). Up to 12 months after stereotactic radiotherapy Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect). Up to 12 months after stereotactic radiotherapy Objective Response Rate according to iRECIST criteria on the irradiated lesion only. Up to 12 months after stereotactic radiotherapy Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect). Up to 12 months after stereotactic radiotherapy Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect). Up to 12 months after stereotactic radiotherapy
Trial Locations
- Locations (1)
Centre Clinical
🇫🇷Soyaux, Charente, France