Colorectal cancer
Conditions
Interventions
Experimental group:Serplulimab combined with bevacizumab plus oxaliplatin and fluorouracil-based chemotherapy (CapeOX/ mFOLFOX6).
Sponsors
Peking University International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female aged 18-75 years (inclusive) when signing the ICF 2.Histopathologically or imaging confirmed RAS-mutated and MSS unresectable metastatic colorectal adenocarcinoma 3.Life expectancy >= 12 weeks 4.Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma 5.For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed 12 months. 6.The interval between the end of previous traditional Chinese medicine treatment and the first dose in this study should be >= 2 weeks 7.Recovering of previous treatment-related AEs to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 500 IU/mL, below the limit of detection is acceptable for inclusion) 12.Hepatitis C Virus (HCV) antibody (-); if HCV antibody is positive (+), HCV-RNA test must be negative for patients to be enrolled. Subjects with co-infection with hepatitis B and C should be excluded (positive for HBsAg or HBcAb test, and positive for HCV antibody test) 13.Adequate major organ functions indicated by the following criteria (no treatment with blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor [CSF] within 14 days prior to the first dose of study drugs): Hematological System:Neutrophils (ANC): >= 1.5×10^9 /L; Platelets (PLT) >= 100×10^9 /L;Hemoglobin (Hb) >= 90g/L Hepatic Function:Total bilirubin (TBIL) = 30 g/L Renal Function: Creatinine (Cr) = 50mL/min if Cr > 1.5 × ULN; (Calculated by Cockcroft-Gault formula) Coagulation Activated partial thromboplastin time(APTT) = 2+, a 24-hour urine protein test will be required, and if the 24-hour urine protein is <1g, the enrollment will be allowed 14.Female subjects of childbearing potential (including subjects whose pregnancy cannot be ruled out by treatment with antineoplastic agents even if they have had amenorrhea for
Exclusion criteria
Exclusion criteria: 1.Other active malignancies within 5 years prior to the first dose of study drugs.Localized tumors that have been cured, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate carcinoma in situ, cervix carcinoma in situ, breast carcinoma in situ, etc., may be enrolled in this study 2.Have confirmed RAS-wild type or MSI-H CRC 3.Subjects without metastasis confirmed by histopathology or imaging 4.Presence of central nervous system (CNS) or leptomeningeal metastases 5.Have received radiotherapy within 6 months prior to the initiation of study treatment, except for palliative radiotherapy for bone disorders at least 14 days prior to initiation of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days prior to the first dose is not allowed 6.Have received postoperative adjuvant therapy with targeted drugs targeting EGFR or VEGF/vascular endothelial growth factor receptor (VEGFR) (including bevacizumab, cetuximab,panitumumab, aflibercept, regorafenib, or biosimilars of the above drugs) 7,Have received treatment with any T-cell co-stimulation or immune checkpoint therapy, including but not limited to CTLA4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells 8.With a known history of severe allergy to any monoclonal antibody or excipients of the study drugs. 9.With uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage after appropriate intervention 10.Cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc interval >= 450 ms in males and >= 470 ms in females) within 6 months (QTc interval is calculated by Fridericia's formula) 11.New York Heart Association (NYHA) Class III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) 7 days) of corticosteroids (> 10 mg/day of prednisone or an equivalent dose of a similar drug) or other immunosuppressive agents for systemic treatment within 14 days prior to the first dose of study drugs or during the study period. In the absence of active autoimmune diseases, the use of inhaled or topical steroids is permitted, as is adrenal hormone rep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall Survival;Disease Control Rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactMeng Chao
Peking University International Hospital
Outcome results
None listed