The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer.
1. What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ? 2. What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed.
Participates will
1. The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks). 2. Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy. 3. Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy. 4. Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent. 5. Pathological assessment
1. Written informed consent must be signed before any trial-related procedures are performed.
2. Male or female, aged ≥18 years and ≤75 years.
3. Histologically or pathologically confirmed rectal adenocarcinoma, with confirmed proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; diagnosed as locally advanced rectal cancer according to AJCC 9th edition, with cTNM staging as cT2-4N1-3M0 based on contrast-enhanced CT/MRI, and the lesion assessed as resectable by the investigator.
4. No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
1.Known squamous cell carcinoma, undifferentiated carcinoma, or other histologic types of colorectal cancer, or adenocarcinoma mixed with other histologic types.
2.Known deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status.
3.Presence of unresectable factors, including unresectability due to tumor-related reasons, presence of surgical contraindications, or subject refusal to undergo surgery.
4.Diagnosis of another malignancy other than colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
Single group
Serplulimab
DrugIntravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment
Bevacizumab
DrugIntravenous infusion, 7.5 mg/kg, Day 1 of every 3-week cycle, neoadjuvant treatment
Oxaliplatin
DrugIntravenous infusion, 130 mg/m², Day 1 of every 3-week cycle, XELOX regimen
Capecitabine
DrugOral administration, 1000 mg/m² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen
pCR rate
The pCR rate and its 95 % confidence interval were calculated
safety analysis
The incidence of adverse events and its 95 % confidence interval were calculated. Adverse events were summarized according to the classification of system organs.
Analysis of objective remission rate
ORR and its 95 % confidence interval were calculated
R0 resection rate analysis
The R0 resection rate and its 95 % confidence interval were calculated
Analysis of anal preservation rate
The anal sphincter preservation rate and its 95 % confidence interval were calculated
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