Actively Recruiting
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Led by City of Hope Medical Center · Updated on 2025-06-26
26
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if appropriate
- Allowed use of archival tumor tissue or obtained new tissue with PI approval
- Age 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed rectal adenocarcinoma within 12 cm of the anal verge
- Radial margin of at least 3mm from mesorectal fascia and no threatened circumferential tumor margin on MRI
- Clinical stage T3N0, TxN1, or TxN2 based on MRI
- No distant metastatic disease on chest, abdomen, and pelvis imaging
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3 if no bone marrow involvement
- Hemoglobin at least 9 g/dL without recent red blood cell transfusion
- Total bilirubin no more than 1.5 times upper limit of normal unless Gilbert's disease
- AST and ALT no more than 3 times upper limit of normal
- Creatinine less than 1.5 times upper limit of normal or adequate clearance
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and after treatment as specified
You will not qualify if you...
- Any prior treatment for rectal cancer including chemotherapy, radiation, or biological therapy
- Any previous immunotherapy
- Use of systemic corticosteroids (>10 mg prednisone daily) within 14 days or immunosuppressive drugs within 30 days before study
- Prior allogeneic organ transplant
- Surgery within 4 weeks before study treatment except minor procedures
- Active or concurrent malignancies except certain curatively resected cancers in remission
- Unstable cardiac disease including recent myocardial infarction or severe heart failure
- Clinically significant uncontrolled illness
- Pregnant or breastfeeding females
- History of allergic reactions to study drugs
- Active or recent autoimmune disease requiring systemic treatment within 2 years
- Recent acute thrombotic venous events unless stable on anticoagulants
- Current or prior interstitial lung disease or pneumonitis requiring high-dose steroids
- Psychiatric or substance abuse disorders interfering with study participation
- Conditions or therapies that may interfere with study results or participation
- Recent severe COVID-19 infection within specified time frames
- Uncontrolled HIV infection or active hepatitis B or C infection
- Grade 2 or higher neuropathy
- Dependence on total parenteral nutrition or intravenous hydration
- Any condition deemed unsafe or noncompliant by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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