Clinical Trials Directory

Trials / Unknown

UnknownNCT05019235

Study of the Association Between Tumor Microenvironment Macrophages and Treatment Response in Squamous Cell Carcinoma of the Anal Canal

Status
Unknown
Phase
Study type
Observational
Enrollment
154 (actual)
Sponsor
Fondation Hôpital Saint-Joseph · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Squamous cell carcinoma of the anal canal is a relatively rare cancer (less than 3% of digestive cancers) but its incidence has been increasing in recent decades, probably because of its association with HPV (human papillomavirus) infection. Its extension is mainly locoregional pelvic by lymphatic route, rarely metastatic. The standard treatment nowadays is radiotherapy combined with chemotherapy for locally advanced tumors (T2 or more corresponding to a size of 2 cm or more, or N+): mitomycin C and 5-FU (or capecitabine). While the 5-year disease control rates are excellent in localized forms, around 80%, for locally advanced tumors, the prognosis is poorer, with only 70% progression-free survival at 3 years in patients treated with radiochemotherapy. In these patients, it seems particularly interesting to understand the mechanisms of tumor resistance to treatments, in order to increase their efficacy and to propose new therapeutic targets. The microenvironment of solid tumors, which has been extensively studied in the last two decades, is now recognized as a major factor in tumor development and invasion. Immune cells, and more particularly macrophages, represent an essential component of the tumor microenvironment, and constitute a link between innate and adaptive responses. The presence of tumor-associated macrophages (TAMs), and in particular M2 macrophages, with an anti-inflammatory and anti-tumor action (as opposed to M1 macrophages which are on the contrary tumoricidal and pro-inflammatory), has been studied in many cancers, such as head and neck squamous cell carcinoma, hepatocellular carcinoma, cervical squamous cell carcinoma, and non-small cell lung cancer. To investigator's knowledge, it has not been studied in squamous cell carcinoma of the anal canal.

Conditions

Timeline

Start date
2021-08-05
Primary completion
2021-09-05
Completion
2023-04-30
First posted
2021-08-24
Last updated
2023-03-07

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05019235. Inclusion in this directory is not an endorsement.