Retrospective Study on the Use of Immunotherapy in Patients With MSI-H Metastatic Colorectal Cancer

NCT ID: NCT04612309

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2025-06-30

Brief Summary

An increasing number of patients with metastatic colorectal cancer (mCRC) are able to receive 3 or more lines of therapy. In this setting, can be recognize treatments such as regorafenib (an oral multikinase inhibitor), trifluridine/tipiracil hydrochloride (TAS-102), an antineoplastic nucleoside analogue, and antibodies anti-epidermal growth factor receptor (EGFR) in patients with RAS wild-type tumors (if no prior exposure to antibodies). Maintaining quality of life is an essential goal for third- and later-line treatments for patients.

The anti-programmed cell death protein 1 (anti-PD-1) immune checkpoint inhibitors, pembrolizumab and nivolumab, were approved in the US by the FDA in 2017, and the combination nivolumab plus ipilimumab (anti CTLA-4) was recently approved by the FDA in 2018, all in the second and later-line setting for patients with microsatellite instability-high (MSI-H) or deficient DNA mismatch repair mCRC whose disease has progressed despite treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. At present, these agents are not approved in Europe for mCRC patients with MSI-H. Clinical trial results and scientific data supported evidence that immunotherapies provide benefit but are limited to the small proportion (< 5%) of patients with MSI-H tumors, in whom they are highly effective. Therefore, patients with MSI-H disease should be referred as expeditiously as possible to receive immune checkpoint inhibitors.

The aim the study is to retrospectively collect data of patients treated with immunotherapy in the context of real clinical practice, in order to describe the real impact in terms of clinical outcomes and tolerability of treatment in common clinical practice.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Treated

Patient with colorectal cancer already treated with immunotherapy

Immunotherapy

Intervention Type: DRUG

patient treated with at least 1 immunotherapy administration

Interventions

Immunotherapy

patient treated with at least 1 immunotherapy administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent for alive patients
• Patients with diagnosis of colorectal cancer with MSI-H
• Patient treated with at least one administration of antibody anti PD-1 for colorectal cancer prior to 30 June 2020 outside clinical trials.
• Availability of the tumor tissue from the primary tumor or a metastatic site for molecular analyses. The availability of tumor tissue is recommended but not mandatory.

Exclusion Criteria

• Patients who received immunotherapy during a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmine Pinto, MD

Role: STUDY_CHAIR

Gruppo Oncologico Italiano di Ricerca Clinica

Locations

Ospedale Ramazzini

Carpi, Modena, Italy

Countries

Italy

Other Identifiers

GOIRC-07-2019

Identifier Type: -

Identifier Source: org_study_id