Planed Organ Preservation for Early- and Intermediate-risk Low Rectal Cancer With Good Response to Neoadjuvant Chemotherapy
On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.
• Age: 18-80 years old; Gender is not limited;
• rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;
• The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The distance between the lower edge of the tumor and the anal verge was ≤5cm measured by digital rectal examination or MRI; ② Clinical stage cT1-3abN0-1M0 (if cT1N0, patients suitable for endoscopic resection should be excluded); ③MRF (-) (\> 1mm), EMVI (±); ④ Lateral lymph nodes were negative and less than 7mm; ⑤ tumor diameter ≤5cm; ⑥ tumor circumference ≤2/3.
• ECOG score: 0-1;
• Patients with primary rectal cancer did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment;
• Normal main organ function, which met the following characteristics: ① Blood routine examination criteria: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophil ≥ 1.5×109/L, PLT≥ 100×109/L; ② Biochemical examination should meet the following criteria: Crea and BIL ≤ 1.0 times the upper limit of normal value (ULN), ALT and AST≤ 2.5 times the upper limit of normal value (ULN), alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤1.5×UNL.
• No history of allergy to 5-Fu or platinum drugs; Women of childbearing age were required to have a negative pregnancy test (serum or urine) 7 days before enrollment and to be willing to use an appropriate method of contraception during the trial and for 8 weeks after the last dose. For men, surgical sterilization or consent to use an appropriate method of contraception for the duration of the trial or for 8 weeks after the last dose;
⁃ (9) The subjects voluntarily joined the study, signed the informed consent form, with good compliance, and cooperated with follow-up.