Although patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.
Age 18~75;
Patient signs informed consent;
ECOG score 0~1;
Initial colonoscopy and pathology: adenocarcinoma;
Age <18 or >75 years;
other malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or largely controlled basal cell carcinoma of the skin;
malignant pleural effusion or malignant ascites;
patients with severe medical comorbidities that preclude radiotherapy and surgery;
Single group
a combination therapy including tislelizumab
Combination productPatients will receive tislelizumab in combination with neoadjuvant radiotherapy and chemotherapy, and will be evaluated 2-3 weeks after completion of the treatment. Those patients who achieve complete clinical regression of the lesion can choose observation, but for those without CCR, surgical resection (TME of the primary lesion, surgical resection of metastases or other destructive local treatment) will be applied. Patients will continue to receive tislelizumab for one year after surgery or during observation. For liver/pulmonary metastasis, the treatment plan is to implement large fraction radiotherapy for 4-8 times. For primary rectum lesion, short-course radiotherapy regimen through intensity-modulated radiotherapy will be applied with dose of 25Gy/5Fx. Immunotherapy contains anti-PD-1 monoclonal antibody, Tislelizumab(200mg, d1, q3w x6, i.v). Chemotherapy adopts CAPEOX plan, including Capecitabine(1000mg/m2 bid, d1-14, p.o) and oxaliplatin(130mg/m2, d1, i.v).
NED rate
rate of no evidence of disease for one year
Overall Survival
For patients who still survive when the final analysis takes place, the date of the last 1 contact will be recorded.
Disease Free Survival
DFS refers to the period of time between the date of surgery and the day of the patient's tumor recurrence or death (earliest occurrence).
Local Recurrence
The date of recurrence is defined as the date on which an objective examination yields a positive result.
Objective Response Rate
Percentage of patients with objective response to primary or metastatic lesions
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