To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
Tislelizumab:200mg,d1,q3w,2 cycles.
Capecitabine:1000mg/m2,d1-14,bid, q3w, 2 cycles.
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Second Hospital of Longyan
Longyan, Fujian, China
Jinjiang Municipal Hospital
Quanzhou, Fujian, China
Complete response (CR) rate
Including pCR and CCR.
Time frame: From enrollment to 3 month and during follow-up
Organ preservation rate
Sphincter-saving rate in enrolled patients
Time frame: 1 year.
Quality of life
EORTC Core Quality of Life questionnaire (QLQ-C30),range from 0-100, with comprehensive assessment indicators, including positive and negative indicators.
Time frame: Before each treatment, before surgery and during follow-up.
3y-DFS
Time frame: From enrollment to 36 month
3-year OS
The percentage of patients enrolled who are still alive three years after their initial enrollment.
Time frame: From enrollment to 36 month
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Oxaliplatin:130mg/m2, d1, q3w, 2 cycles