NCT07040098View on ClinicalTrials.gov

Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2030

Conditions
Locally Advanced Rectal Cancer (LARC)
Interventions
DRUG

Sintilimab

PD-1 inhibitor

RADIATION

Short-course radiotherapy

Pelvic radiation, SCRT, 5 Gy x 5 alone

RADIATION

Long-course concurrent chemoradiotherapy

Pelvic radiation, 50 Gy in 25 fractions over 5 weeks, concurrently with capecitabine (825 mg/m2, twice a day).

COMBINATION_PRODUCT

CAPOX

chemotherapy regimen, Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle)

Trial Locations (2)

Unknown

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing

RECRUITING

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Shenzhen

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

NCT07040098 - Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter