Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

Inclusion criteria

• Patient is 18-75 years old at the time of signing the informed consent form.
• ECOG performance status 0-1.
• Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
• No distant metastasis lesions outside the pelvic.
• No prior radiotherapy within 6 months.
• Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.
• Life expectancy at least 24 weeks.
• Adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
• Non pregnancy or lactation.
• Fully informed and willing to provide written informed consent for the trial.

Exclusion criteria

• Neutrophil < 1.5×10^9/L, PLT < 75×10^9/L.
• TBIL > 1.5 ULN.
• AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
• Cr > 1.5 ULN.
• Serious electrolyte abnormalities.
• Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months.
• Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.
• Congestive cardiac failure ≥ NYHA grade 2.
• Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml; hepatitis C defined as HCV-RNA higher than lower limit of detection) or hepatitis B and hepatitis C virus co-infection.
• Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.
• Suspected autoimmune disease.
• Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
• Suspected allergic to any drugs used in the trial.
• History of any immune checkpoint inhibitor therapy.
• Clinically detectable second primary malignancy, or history of other malignancies within 5 years.
• Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication; Or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
• The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
• Serious mental abnormalities.