OncoMatch/Clinical Trials/NCT06780787
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Is NCT06780787 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for rectal adenocarcinoma.
Treatment: Balstilimab · Botensilimab · Capecitabine · Fluorouracil · Leucovorin Calcium · Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage IIA, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy
Cannot have received: radiation therapy
Any treatment for rectal cancer prior to enrollment that includes (but not limited to) radiation
Cannot have received: biological therapy
Any treatment for rectal cancer prior to enrollment that includes (but not limited to) biological therapy
Cannot have received: immunotherapy
Any prior immunotherapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3 (without bone marrow involvement); Hemoglobin ≥ 9g/dL (no transfusions within 14 days of assessment)
Kidney function
Creatinine < 1.5 x ULN or clearance of ≥ 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN
Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's disease); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Creatinine < 1.5 x ULN or clearance of ≥ 40 mL/min; ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify