pMMR/MSS locally advanced low rectal cancer
Conditions
Interventions
Experimental Group:Neoadjuvant Chemoradiotherapy,Eparolimab and Toripalimab
Sponsors
Central Hospital of Guangdong Provincial Nongken
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced low rectal cancer confirmed by histopathology or cytopathology and mismatch repair protein (MMR) testing as pMMR or genetic testing as MSS; 2. (1) Clinical stage: cT3-4N1-2M0; (2) Distance from tumor to anus =5 cm; (3) no distant metastasis. 3. Age >=18 years old and =1.5×10^9 /L, platelet count (PLT) >=100×10^9 /L, hemoglobin (HGB) >=80g/L; (2) normal liver and kidney function; Normal renal function: serum creatinine <=1.5mg/dl(133µmol/L) and or creatinine clearance =60ml/min; Normal liver function: total serum bilirubin level <=1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) & alanine aminotransferase (ALT) 2.5 times the ULN. (3) Coagulation: international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN. 7. Patients voluntarily participated in the study, provided written informed consent, and adhered to protocol-specified visits and procedures. 8. Within 28 days before enrollment, women of childbearing age had to confirm a negative serum pregnancy test and agree to use effective contraception while using the study drug and for 60 days after the last dose.
Exclusion criteria
Exclusion criteria: 1)Active malignant tumor other than rectal cancer, either currently or in the past. 2)History of major surgery within 4 weeks prior to the start of study treatment. 3)Concurrent participation in other interventional clinical studies (except for observational studies or being in the follow-up phase of an interventional study). 4)Prior treatment with PD-1, PD-L1, PD-L2, or CTLA4, CD137 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or immune checkpoint pathways; 5)Receipt of drugs with immunomodulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first dose. Receipt of live attenuated vaccines within 4 weeks prior to the first dose or planned receipt during the study treatment period. 6)History of autoimmune diseases, hematological diseases, or organ transplantation; 7) Complicated with other serious diseases, including uncontrolled active infection, severe electrolyte imbalance, bleeding tendency, and any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to study enrollment. 8)Coronary heart disease, arrhythmia, heart failure, or other cardiovascular diseases of grade >=II. 9) Complicated with other uncontrolled malignant tumors. 10)Pregnant or lactating women. 11)Severe brain disease or mental illness that impairs the patient’s ability to provide self-report.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Clinical Response;Major Pathological Response;Tumor Regression Grade;Neoadju? vant rectal score, NAR ;Objective response rate;R0 resection rate;Sphincter preservation rate; | — |
Countries
China
Contacts
Public ContactQiyun Li
Central Hospital of Guangdong Provincial Nongken
Outcome results
None listed