Metastatic Colorectal Cancer
Conditions
Interventions
Experimental: Serplulima +Bevacizumab+XELOX
Serplulimab (HLX10) in combination with Bevacizumab and chemotherapy (XELOX)
-Serplulimab (HLX10): a single fixed dose of 300 mg, intravenous infusion (IV),
Sponsors
Peng Danyang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible for the study if they meet all of the following criteria: 1.Male or female aged 18-75 years (inclusive) when signing the ICF 2.Histopathologically confirmed unresectable metastatic/recurrent 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): Hematologic system:Absolute neutrophil count (ANC) >= 1.5x10 9 /L; Platelet (PLT) >= 100x10 9 /L;Hemoglobin (Hb) >=90g/L Liver function:Total bilirubin (TBIL) == 30 g/L Renal function: Creatinine (Cr) == 50mL/min if Cr > 1.5xULN; (Calculated by Cockcroft-Gault formula) Coagulation function:Activated partial thromboplastin time(APTT) == 2+, a 24-hour protein urine test is required, and subjects with 24-hour urine protein of <1g are eligible to be enrolled. 14.Female subjects of childbearing potential (including subjects whose pregnancy cannot be ruled out by treatment with anti
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 MSI-H CRC 3. Subjects with oligometastatic liver disease and presenting the potential for becoming resectable 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 CTLA-4 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 permi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) assessed by the Independent Radiology Review Committee(IRRC) per RECIST v1.1, Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS) (assessed by the investigator per RECIST v1.1), Progression-free survival in the next line of treatment(PFS2) (assessed by the investigator per RECIST v1.1), Objective response rate(ORR), Duration of response(DOR),Disease control rate(DCR), and quality of life assessment, as well as safety assessment (including immunogenicity) and measurement of serum concentrations of study drugs. | — |
Countries
China, Indonesia, Japan
Contacts
Public ContactXiao Han
Tigerise Inc.
Outcome results
None listed