To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f
130 mg/m²,d1, q3w ,4 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: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.
Organ Preservation Rate
Sphincter-saving rate in enrolled patients
Time frame: 1 year.
Surgical Complications
Incidence and severity of postoperative complications.
Time frame: Within 30 days post-surgery
the 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: Baseline, before surgery, and up to 12 months after surgery
Grade ≥3 Adverse Event Rate
Incidence of grade 3 or higher adverse events graded according to CTCAE v4.0.
Time frame: From start of treatment to 30 days after last dose, up to approximately 6 months
3y-DFS
Proportion of patients without disease recurrence or death from any cause at 3 years.
Time frame: From enrollment to 36 month
3y-LRFS
Proportion of patients without local recurrence at 3 years.
Time frame: From enrollment to 36 month
3y-OS
Proportion of patients alive at 3 years.
Time frame: From enrollment to 36 month
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1000 mg/m, d1-14,bid,q3w, 4 cycles
200mg,d1,q3w,4 cycles
825 mg/m² ,BID ,on radiation days
200mg,d1,q3w,3 cycles