FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery

This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications invo

Trial Details

NCT ID

NCT06780787

Phase

PHASE2

Sponsor

City of Hope Medical Center

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Balstilimab
Biospecimen Collection
Botensilimab
Capecitabine
Computed Tomography
Digital Rectal Examination

Locations (sample)

Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval

For full eligibility, visit ClinicalTrials.gov.

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