Colorectal cancer
Conditions
Interventions
Experimental group:After enrollment, patients were treated with serplulimab + bevacizumab + standard chemotherapy (XELOX/mXELIRI), of which XELOX/mXELIRI was used for up to 6 cycles or until disease p
Bevacizumab: 7.5mg/kg, d1, q3w
XELOX: oxaliplatin 130mg/m?, dl
capecitabine, 1000mg/m?, bid, d1-14: q3w
mXELIRI: irinotecan 200mg/m?, dl
capecitabine, 800mg/m?, bid, d1-14
q3w.
During maintenance therapy: capecitabine, 1000mg/m?, bid, d1-14: q3w.
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed MSS or pMMR advanced metastatic colorectal adenocarcinoma; 2.Disease progression after first line standard treatment ( two drugs-chemotherapy combined with targeted drugs) ; 3.Age >= 18 years, no gender restriction.; 4.Estimated survival >= 3 months 5.ECOG score:0-1; 6.According to the RECIST 1.1 criteria, at least one measurable lesion must be present. 7.Major organ functions are well-maintained, with relevant test indicators meeting the following requirements within 14 days prior to enrollment: i) Hemoglobin >= 90g/L (no blood transfusion within the past 14 days), Neutrophil count >= 1.5×10^9/L, Platelet count >= 80×10^9/L; ii) Total bilirubin (TBIL) = 60 ml/min (calculated according to the Cockcroft-Gault formula). 8.Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= 50%; 9.For patients of childbearing potential, agreement to use medically recognized contraceptive measures during the study treatment period and for 6 months after the end of the study treatment is required; Female patients must test negative in a serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding; 10.Sign the informed consent form and demonstrate good compliance.
Exclusion criteria
Exclusion criteria: 1.The patient is currently participating in other clinical trials of medications (excluding non-interventional clinical trials). 2. The patient has had or currently has other malignant tumors, except for basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast carcinoma in situ that have been cured. 3.Patients with known central nervous system (CNS) metastases. For patients clinically suspected of having CNS metastases, a CT or MRI examination must be performed within 28 days before the start of treatment to rule out CNS metastases; 4.Patients with clinical symptoms requiring clinical intervention for pleural effusion or ascites; 5.Patients who are using immunosuppressive agents for any reason, or who are on systemic steroid therapy to achieve immunosuppressive purposes (dose >10mg/day prednisone or equivalent steroids); 6.Patients with any active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis); 7.Patients with a history of organ transplantation; 8.Patients with the following conditions: a) Hyperthyroidism; b) Vitiligo; c) History of inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease, or a history of chronic diarrhea diseases such as irritable bowel syndrome; d) History of sarcoidosis or tuberculosis; e) History of active hepatitis B or C, and HIV infection; f) New diagnosis of angina within 3 months prior to screening or myocardial infarction within 6 months prior to screening; arrhythmia (including QTcF: male>=450ms, female >=470ms) requiring long-term use of antiarrhythmic drugs, and New York Heart Association (NYHA) class =II heart failure; g) Asthma requiring bronchodilator intervention (patients with childhood asthma who are fully remitted and do not require any intervention in adulthood can be included); h) Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, or other lung inflammations requiring corticosteroid treatment; i) Patients with a history of substance abuse that cannot be quit, or with mental disorders; 9.Urinalysis indicating proteinuria of >=2+ and 24-hour urine protein quantification >1.0g; 10.Any other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;Safety; | — |
Countries
China
Contacts
Public ContactLv Jing
The Affiliated Hospital of Qingdao University
Outcome results
None listed