Evaluating immune cell characteristics in patients with non-metastatic rectal cancer

Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Adenocarcinoma Treated With Preoperative Radiochemotherapy With or Without Initial Chemotherapy

This study is testing how certain immune cells in the blood of patients with non-metastatic rectal cancer respond to treatment to see if they can help improve care and outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Sainte Catherine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Avignon)
• Trial ID: NCT06536127 on ClinicalTrials.gov

What this trial studies

This study focuses on assessing the phenotype of circulating natural killer (NK) cells and the ImmunoScore® in patients diagnosed with non-metastatic rectal cancer. Participants will undergo standardized chemoradiotherapy treatment, and blood samples will be collected to analyze immune responses. The study aims to understand the relationship between immune cell characteristics and treatment outcomes, potentially guiding future therapeutic strategies. By evaluating these immune parameters, the research seeks to improve patient management and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed adenocarcinoma of the rectum who are scheduled to receive specific chemoradiotherapy treatments.

Not a fit: Patients with metastatic or unresectable disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of immune responses in rectal cancer, leading to improved treatment strategies and better patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies evaluating immune cell characteristics in cancer have shown promising results, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

Age ≥ 18 years

Histologically proven adenocarcinoma of the rectum

Patient with rectal cancer (cT2-4N0 or cT1-T4N+)

Patients whose planned treatment is: standardised CTRT comprising 50Gy intensity-modulated irradiation and Capecitabine with or without additional dose (contact therapy). Neoadjuvant chemotherapy with FOLFOX or FOLFIRINOX may be given prior to RTCT.

IMRT-type radiotherapy treatment

Women of childbearing age must provide proof of effective contraception (sterilisation for you and/or your partner, transdermal, vaginal, oral, subcutaneous or injectable hormonal contraception and intrauterine devices).

Person affiliated to or benefiting from a social security scheme.

Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria:

Metastatic disease

Unresectable disease

History of pelvic irradiation or contraindication to pelvic irradiation

Contraindications to the administration of one of the following chemotherapy drugs: irinotecan, oxaliplatin, or 5 FU, capecitabine

Presence of an evolving concomitant neoplasia other than the following: i/ treated in situ cervical cancer, ii/ spino or basal cell skin cancer, iii/ cancer in complete remission for more than 3 years.

Psychological, social, family or geographical conditions preventing compliance with the study protocol and follow-up examinations.

Persons under legal protection (guardianship, curatorship, safeguard of justice)

Persons deprived of their liberty

Where this trial is running

Avignon

• Icap — Avignon, France (Recruiting)

Study contacts

• Study coordinator: Léa Retournard, MDV

Conditions Rectal Cancer; Non Metastatic Cancer