Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 19, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2030

Conditions
Rectal Adenocarcinoma
Interventions
RADIATION

Reduced-field short-course radiotherapy

A dose of 25 Gy in 5 fractions was delivered as short-course radiotherapy, with one fraction per day, completing treatment within one week. The target volume was delineated using both CT and MRI. Compared to conventional radiotherapy fields, the irradiated volume was significantly reduced to include only the primary tumor and any metastatic lymph nodes as identified on MRI and CT.

DRUG

Immunotherapy combined with chemotherapy

After completion of radiotherapy, chemotherapy with the XELOX regimen (oxaliplatin 130 mg/m² on day 1 plus capecitabine 1500 mg/m² on days 1-14, every 3 weeks) was initiated in combination with sintilimab immunotherapy (200 mg every 3 weeks) for 4 cycles.

RADIATION

Standard short-course radiotherapy

"Patients in the standard short-course radiotherapy group will receive 25 Gy in 5 fractions, once daily. Target volumes will be delineated according to the 2023 Guidelines for Target Volume Delineation and Planning of Rectal Cancer (National Cancer Center/National Cancer Quality Control Center), including the primary tumor, mesorectal region, and internal iliac and obturator lymph node drainage areas."

RADIATION

Standard long-course radiotherapy

Patients in the standard long-course radiotherapy group will receive 50 Gy in 25 fractions, once daily, five days per week, with concurrent oral capecitabine chemotherapy. Target volumes will be delineated according to the 2023 Guidelines for Target Volume Delineation and Planning of Rectal Cancer (National Cancer Center/National Cancer Quality Control Center), including the primary tumor, mesorectal region, and internal iliac and obturator lymph node drainage areas.

DRUG

Chemotherapy

Two weeks after the completion of radiotherapy, patients will receive four cycles of CAPOX chemotherapy.

Trial Locations (1)

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

All Listed Sponsors
lead

Longhao Li

OTHER