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NCT06780787 · ClinicalTrials.gov registry record · Phase 2
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
A Phase 2 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06780787: Recruiting Phase 2 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT06780787 is a Phase 2 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 26 participants, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06780787, a Phase 2 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Data will be summarized using descriptive statistics for continuous variables and frequencies and percentages will be used for categorical variables. Univariate logistic regression was used to estimate odds ratios (OR) and 90% confidence interval (CI) for cCR
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- BIOLOGICAL Botensilimab
- BIOLOGICAL Balstilimab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-05-20 |
| Est. Completion | 2027-11-05 |
| Phase | Phase 2 |
What NCT06780787 shows while recruiting
NCT06780787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06780787 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06780787 about?
NCT06780787 is a clinical study titled "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...
What is the current status of trial NCT06780787?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2025-05-20. Estimated completion is 2027-11-05.
What conditions does trial NCT06780787 study?
This clinical trial studies the following conditions: Rectal Adenocarcinoma, Stage III Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8.
What interventions are being tested in trial NCT06780787?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Botensilimab (BIOLOGICAL), Balstilimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06780787?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06780787 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06780787's enrollment target sits among peer trials
26 13th of 17 higher than 5 of 17 other Rectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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