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

StatusRecruiting
PhasePhase 2
Started2025-05-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
minor
Study Status v3
Re-verified, no change to tracked fields
2025-06-24
minor
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2025-05-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12-23→2027-11-05
Completion date2026-12-23→2027-11-05
Start dateestimated 2025-06-30→confirmed 2025-05-20
Study sitesdetails revised at 1 of 1 site
2025-01-13
minor
Original filing
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 involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.
Trial Details
NCT Number NCT06780787
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
Enrollment 26 participants
Start Date 2025-05-20
Primary Completion 2027-11-05 (estimated)
Study Completion 2027-11-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-29