FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wyrażenie świadomej zgody na udział w badaniu.
- •Zgoda na użycie próbek guza pobranych wcześniej do badań.
- •Wiek co najmniej 18 lat.
- •Potwierdzony histopatologicznie rak odbytnicy (gruczolakorak).
- •Guz w odbytnicy nieprzekraczający 12 cm od odbytu.
- •Brak przerzutów do innych części ciała.
- •Ogólny dobry stan zdrowia pozwalający na udział w badaniu (określany przez skalę ECOG).
✗ Disqualifies
- •Brak możliwości udostępnienia wcześniejszych próbek guza do badań (bez zgody lekarza prowadzącego).
- •Kobiety w ciąży lub karmiące piersią.
- •Niektóre choroby wątroby lub nerek.
- •Zbyt niskie wyniki badań krwi (neutrofile, płytki krwi, hemoglobina).
- •Chęć posiadania dzieci w najbliższym czasie (wymagane stosowanie antykoncepcji).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 29, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
City of Hope Medical Center
Duarte, United States
Trial contact
Marwan Fakih
Marwan Fakih
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.