Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 20, 2024

Primary Completion Date

September 20, 2026

Study Completion Date

September 20, 2029

Conditions
Rectal Cancer
Interventions
RADIATION

moderately hypofractionated radiotherapy

35 Gy in 10 fractions to mesorectal and metastatic lymph nodes, and 30 Gy in 10 fractions to pelvic lymphatic drainage area, weekly over 5 days at 3-3.5 Gy/day.

DRUG

chemotherapy

CapeOx-Capecitabine 1000 mg/m² orally twice daily (days 1-14, every 21 days) + Oxaliplatin 130 mg/m² IV (day 1, every 21 days).

DRUG

immunotherapy

Serplulimab 300 mg IV infusion on day 1 every 21 days.

PROCEDURE

Total mesorectal excision (TME) surgery

Total mesorectal excision (TME) surgery assessment post 3 cycles of chemotherapy and immunotherapy; eligible patients undergo TME surgery.

Trial Locations (1)

200030

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Shanghai Zhongshan Hospital

OTHER

NCT06599827 - Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC | Biotech Hunter | Biotech Hunter