A Phase 2 interventional study of Capecitabine and Radiation therapy in Rectal Cancer, sponsored by Baruch Brenner. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Baruch Brenner · Phase 2, Interventional, and Treatment
This is a phase II, prospective, open label, one-center study for evaluation of the addition of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced rectal cancer patients. Subjects must have received no prior treatment for rectal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors.
Eligible subjects will receive chemoradiation for a period of 5 weeks, 6 cycles of chemo-immunotherapy (mFOLFOX6 + nivolumab) for a period of 12 weeks, once every 2 weeks, and will undergo surgery after 4 weeks.
Patients with cCR will be offered the alternative strategy of WW. Post-study systemic treatment, up to 4 cycles of mFOLFOX6, will be left to the discretion of the treating physician. This will be started 4-8 weeks post-operatively, or immediately after the demonstration of cCR in patients determined to undergo WW.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 29 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Baruch Brenner is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will receive chemoradiation followed by chemotherapy and nivolumab as neoadjuvant treatment
Drug: Capecitabine · Radiation: Radiation therapy · Drug: mFOLFOX6 · Drug: Nivolumab
Capecitabine 825 mg/m2 orally twice-daily, 5 days a week for a total of 28 days, given with radiation therapy
Also known as: Xeloda
1.8 Gy/day, 5 days a week for a total of 28 days, given with Capecitabine
oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and fluorouracil 400 mg/m2 IV, fluorouracil 2400 mg/m2 IV (a 46 hrs CI), day 1 of each treatment cycle, every 2 weeks, given with nivolumab
Nivolumab 240mg IV, day 1 of each treatment cycle, every two weeks, given with mFOLFOX6
Also known as: Opdivo
pathological complete response (pCR) rate
pCR is defined when no tumor is found on pathology review of the surgical specimen (TRG -0)
Time frame: Time from start of neoadjuvant treatment until surgical resection, assessed up to 24 months
Incidence of Treatment-Emergent Adverse Events (Safety)
Treatment-emergent AEs will be graded according to NCI CTCAE v4.0, vital signs and clinical laboratory
Time frame: Time from screening until the end of study drug administration, assessed up to 24 months
modified pathological complete response
We defined a novel primary endpoint, combining pathological complete response (pCR) rate among operated patients and long-term (≥12 months) clinical complete response (cCR) rate for those electing watchful waiting, into a composite endpoint of modified pCR (mpCR) rate.
Time frame: Time from start of neoadjuvant treatment until surgical resection in operated patients (pCR) and long-term (≥12 months) clinical complete response (cCR) in unoperated patients, assessed up to 24 months.
Disease Free Survival (DFS)
DFS will be censored for patients who are alive and free of progression at the time of last follow-up. DFS rate will be estimated using the Kaplan-Meier method
Time frame: Time from the first day of treatment to the first event of: loco-regional failure, metastatic recurrence, the appearance of a secondary colorectal cancer or death from any cause, assessed up to 42 months
Overall Survival (OS)
Patients who are still alive when last traced will be censored at the date of last follow-up. OS rate will be estimated using the Kaplan-Meier method
Time frame: The time interval between the first day of treatment and the date of death of any cause, assessed up to 66 months
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Baruch Brenner