Global cancer statistics, 2012.
Lindsey A Torre, Freddie Bray, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/25651787Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06061705
Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies
Led by Fondation Hôpital Saint-Joseph · Updated on 2025-06-24
100
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating squamous cell carcinoma of the upper aerodigestive tract (CEVADS), a common and serious cancer with poor long-term survival despite current treatments like radiotherapy, surgery, and chemotherapy. This trial aims to better understand why only about 20% of patients respond well to PD-1 inhibitor immunotherapies by studying tumor markers, immune cells, and bacteria in the tumor environment. The study focuses on improving patient selection for immunotherapy and exploring resistance mechanisms to develop better treatment strategies. Participants will receive immunotherapy, and after starting treatment, an ENT surgeon will perform a cervico-facial tumor biopsy between 30 and 180 days if the tumor is accessible and the procedure is safe. This biopsy includes superficial sampling of the external tumor lesion under local anesthesia. Additionally, blood and saliva samples will be collected to analyze immune responses and the presence of Fusobacterium nucleatum bacteria in the oral microbiota. Throughout the study, researchers will monitor histological markers linked to treatment benefit, survival, and PD-L1 expression, as well as immune responses to F. nucleatum. The main outcome will be assessed at six months. Participants will be involved in biopsies, blood and saliva sample collection, and clinical evaluations. The study will help identify factors influencing response or resistance to immunotherapy in CEVADS patients.
CONDITIONS
Brief Title
Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Histologically confirmed squamous cell carcinoma involving the oral cavity, oropharynx, hypopharynx, or larynx
- Patients with a first recurrence (locoregional or metastatic) who are candidates for immunotherapy
- Affiliated to a health insurance plan
- French-speaking patients
- Patients able to give free, informed, and written consent
You will not qualify if you...
- Patients with contraindications to immunotherapy, such as transplant recipients
- Pregnant or breastfeeding patients
- Patients under guardianship, curatorship, or court protection
- Patients deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Immunotherapy Treatment Period
Duration - Between Day 1 and Day 180
Participants receive immunotherapy as part of their treatment.
Tumor Biopsy Procedure
Duration - Between Day 30 and Day 180
An ENT surgeon performs a cervico-facial tumor biopsy between Day 30 and Day 180 if the tumor is accessible and it can be done safely under local anesthetic. Participants also provide blood and saliva samples during this period.
1 to 2 visits depending on tumor accessibility and biopsy scheduling
Trial Site Locations
Total: 3 locations
1
Hôpital Saint-Joseph
Paris, France, 75014
Actively Recruiting
2
Hôpital Bichat
Paris, France
Actively Recruiting
3
Hôpital Saint-Louis
Paris, France
Not Yet Recruiting
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Research Team
E
Eric Raymond, MD, PhD
H
Helene BEAUSSIER, PharmD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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