Adjuvant Chemotherapy in High Risk Stage II Colon Cancer
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
- Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is
still debated. Several high-risk features may help to stratify stage II cancer patients
into groups that will truly benefit from adjuvant chemotherapy. However, those factors
are rather subjective, and no specific trial has been designed to answer the high-risk
stage II colon cancer question directly.
- Immunoscore® Colon, an in vitro diagnostic test, which quantifies the density of CD3+
and CD8+ T lymphocyte populations in the center the tumor (CT) and its invasive margin
(IM) using immunohistochemistry and automated image analysis. Immunoscore® has been
extensively validated as a prognostic biomarker in early stage CC patients. This unique
diagnostic assay measuring host immune response at the tumor site may inform the
decision to administer adjuvant chemotherapy in resected Stage II and III CC patients.
- This randomized trial is studying how observation compares to adjuvant chemotherapy
(investigator's choice) in stage II colon cancer patients with high-risk features and
High-Immunoscore®. The trial would represent a unique opportunity to classify stage II
CC patients based on their tumor microenvironment with the aim to provide efficient
patient stratification to improve clinical care.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine