locally advanced rectal cancer,LARC
Conditions
Interventions
MSI-H:Tislelizumab 200mg ivdrop every 3 weeks for 4 cycles
MSS-RASwt/BRAFwt:mFolfOx6 chemotherapy combined with EGFR monoclonal antibody and Tislelizumab
MSS-RASmt/BRAFmt:Standard neoadjuvant chemoradiotherapy regimen combined with Tislelizumab
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and sign the informed consent voluntarily; 2. Pathologically proven rectal adenocarcinoma, and meets the following criteria: (1)The clinical stage is cT3-4N0M0 or cT1-4N+M0; (2)Distance from the lower edge of the tumor to anus under 10cm; (3)No distant metastasis; 3. Over 18 years old, unlimited gender, ECOG score 0-2; 4. Physical condition and organ function allow for major abdominal surgery; 5. Willing and able to adhere to the study protocol during the study; 6. Consent to investigators to use blood and pathological slides during the study period; 7. Major organ functions meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards): (1)Routine blood test: (no blood transfusion, no granulocyte colony-stimulating factor, no drug correction within 14 days before test): a) neutrophils =1.5×10^9/L; b) platelets =75×10^9/L; c) Hemoglobin=90g/L (2)Biochemical tests: (no albumin transfusion within 14 days before the test): a) Serum creatinine=1.5 x ULN (Upper limit of normal), or creatinine clearance rate>50 mL/min; b) Serum total bilirubin=1.5 x ULN ;c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT)=2.5 x ULN (3)Coagulation function: International normalized ratio (INR) = 2.3 or prothrombin time (PT) exceeding the range of normal controls = 6 seconds 8. Women of childbearing potential must confirm a negative serum pregnancy test within 28 days prior to enrollment and agree to use effective contraception during the trial drug administration and for 60 days after the last dose. Women of childbearing age in this protocol are defined as sexually mature women who: 1) have not undergone a hysterectomy or bilateral oophorectomy; 2) have not had spontaneous menopause for 24 consecutive months (amenorrhea after cancer treatment does not preclude fertility), i.e. Menstruation occurred at any time in the previous 24 consecutive months. *Female spouses of male subjects who are of childbearing age should also follow the contraceptive requirements above.
Exclusion criteria
Exclusion criteria: 1. Current or past active malignancy other than rectal cancer; 2. Any other form of antitumor therapy currently or in the past; 3. Major surgery within 4 weeks prior to the start of study treatment; 4. Presence of any condition that affects the absorption of capecitabine in the gastrointestinal tract; 5. Severe uncontrolled recurrent infection or other concomitant disease; 6. Allergic to any of the study drug ingredients; 7. Severe concomitant diseases that make survival under 5 years; 8. Present or past moderate or severe liver and kidney impairment; 9. Current or previous exposure to other investigational drugs or any immunotherapy; 10. About to undergo or previously received an organ or allogeneic bone marrow transplant; 11. Administration of immunosuppressive or systemic corticosteroids for immunosuppressive purposes within 1 month prior to initiation of study treatment; 12. Congenital or acquired immunodeficiency (eg. HIV-infected patients); 13. If there is a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator assesses whether it prevents signing informed consent or affects patient compliance with oral medications; 14. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities or accompanied by family or social factors, which will affect the safety of patients; 15. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| neoadjuvant rectal score(NAR);objective remission rate(ORR);R0 resection rate;Anal retention rate;disease free survival rates(DFS);overall survival(OS); | — |
Countries
China
Contacts
Public ContactGang Liu
Tianjin Medical University General Hospital
Outcome results
None listed