Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Leucovorin

Fluorouracil

Immunomodulating Agents

Oxaliplatin

1. Week 1: D1-5: radiotherapy 25 Gy in 5 fractions
2. mFOLFOX-6: Oxaliplatin 85 mg/m2 in a 2-hour infusion Leucovorin 400 mg/m² over 2 hours Bolus fluorouracil 400 mg/m² followed by a 48-hour infusion of fluorouracil 2,400 mg/m² + COMPOUND 2055269 10 mg/kg every 2 weeks (first administration at D15, for a total of 6 cycles)
3. Week 16 or 17 (2 to 3 weeks after last cycle of chemotherapy + COMPOUND 2055269): Total Mesorectal Excision

COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles

COMPOUND 2055269

Radiotherapy 25 Gy to be given on Days 1-5

Radiation Therapy

mFOLFOX

Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269

Total Mesorectal Excision

Ali I Shamseddine, M.D.

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

COMPOUND 2055269 has demonstrated meaningful clinical activity across various tumor types and treatment settings. No clinical trial is conducted over COMPOUND 2055269 in locally-advanced rectal adenocarcinoma.

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

Will be done via pathologic assessment on the surgical specimen

1) Progression free survival is measured by imaging and serial tumor markers during follow up visits

2) PD-L1 \& T cell infiltration is measured by a pathology assessment on day 10 and after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma	NCT03503630	Locally Advance...	COMPOUND 205526... Radiation Thera... mFOLFOX Total Mesorecta...	18 Years -	American University of Beirut Medical Center
Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma	NCT03503630	Locally Advance...	COMPOUND 205526... Radiation Thera... mFOLFOX Total Mesorecta...	18 Years -	American University of Beirut Medical Center

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