MSS/pMMR type colorectal cancer
Conditions
Interventions
Group A:Cycle 1: PDT + serplulimab + bevacizumab
Subsequent cycles: serplulimab + XELOX + bevacizumab
Group B:Serplulimab + XELOX + bevacizumab
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in the study, sign the informed consent form, and be able to comply with study visits and procedures 2.PD-1/PD-L1 testing performed 3.Age >=18 and =6 months 10.Adequate organ function, including: (1)Absolute neutrophil count >=1.5 × 10^9/L (2)Platelet count >=80 × 10^9/L (3)Hemoglobin >=90 g/L (4)Serum albumin >=28 g/L (5)TSH = 40 mL/min (10)INR or APTT =2+, 24-hour urine protein must be <1.0 g/24 h 11.For women of childbearing potential who are not surgically sterilized, serum or urine HCG must be negative within 7 days prior to enrollment 12.Women of childbearing potential and non-sterilized women must use a medically approved contraceptive method during study treatment and for 6 months after the end of treatment, and must not be breastfeeding; Men whose partners are women of childbearing potential must use effective contraception during the study and for 6 months after the last dose
Exclusion criteria
Exclusion criteria: 1.Currently participating in another clinical trial with treatment, or having participated in another investigational drug study within 4 weeks prior to study treatment; major surgery within 4 weeks prior to randomization without adequate recovery 2.Active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; exceptions may include:hypothyroidism controlled with hormone replacement; type 1 diabetes controlled with insulin; childhood asthma fully resolved; vitiligo 3.Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 7 days prior to randomization (dose >10 mg/day prednisone equivalent) 4.Any active malignancy within the past 5 years, except the cancer under study and cured localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate carcinoma in situ 5.Prior treatment with sintilimab or S-1 (tegafur/gimeracil/oteracil) 6.Known central nervous system metastases (MRI required if suspected) or history of hepatic encephalopathy 7.History of noninfectious pneumonitis requiring steroid treatment within 6 months 8.Active infection; unexplained fever >=38.5°C within 7 days before dosing; or baseline WBC >15 × 10^9/L; serious acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except active hepatitis assessed separately) 9.Other conditions judged by the investigator to affect study results or subject safety, including alcoholism, drug abuse, severe comorbidities, severe psychiatric disease, major laboratory abnormalities, or social/family factors compromising compliance 10.Congenital or acquired immunodeficiency, including HIV infection 11.Active HBV or HCV infection 12.Active HBV defined as known HBsAg positivity with HBV DNA >2000 IU/mL; active HCV defined as known HCV antibody positivity with HCV RNA above the lower limit of detection 13.Receipt of a live attenuated vaccine within 4 weeks prior to randomization, or planned need for such vaccination during anti-PD-1 therapy or within 5 months after the last dose 14.More than a small amount of pericardial effusion, uncontrolled pleural effusion, or ascites at screening 15.Large pleural or abdominal effusion requiring drainage during screening 16.Serious cardiovascular or cerebrovascular disease, including: (1)NYHA Class III or IV heart failure within 6 months (2)LVEF =3 cardiovascular/cerebrovascular events within 6 months 17.Known severe allergy to any monoclonal antibody or anti-angiogenic targeted drug 18.Pregnant or lactating women; women planning pregnancy during the study period (from screening to 120 days after the last study procedure), or male subjects whose spouses are pregnant 19.Any other condition considered by the investigator to warrant exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;R0 resection rate;Major pathological response rate;Disease control rate;Disease-free survival;Objective response rate;1-year overall survival (OS) rate;Perioperative complication rate;Safety; | — |
Countries
China
Contacts
Public ContactHao Chen
Shanghai General Hospital
Outcome results
None listed