Colorectal cancer
Conditions
Interventions
experimental group:Gossypol acetate tablets combined with bevacizumab and FOLFIRI
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female aged >= 18 years old; 2. Colonic or rectal adenocarcinoma diagnosed by histopathology or cytology; 3. Diagnosed as an unresectable metastatic disease through imaging examination; 4. At least one measurable lesion (according to RECIST v1.1); 5. Have received first-line treatment based on oxaliplatin; 6. ECOG score 0-2; 7. Expected survival time >= 3 months; 8. Bone marrow function: neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 100 × 10^9/L, hemoglobin (Hb) >= 90g/L, white blood cell count (WBC) >= 3.0 × 10^9/L; 9. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) = 60 ml/min (calculated according to Cockroft Gault), urinary protein<2+; 11. Coagulation function: Normal coagulation function (International Normalized Ratio INR <= 1.5); 12. Patients and/or legal representatives who understand the situation of this study voluntarily agree to participate in this trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have suffered from other malignant tumors within the past 5 years (excluding cured carcinoma in situ and basal cell carcinoma of the skin); 2. Previously received chemotherapy based on irinotecan/irinotecan liposomes; 3. A large amount of pleural effusion or ascites requires intervention and treatment; 4. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment, defined as persistent signs/symptoms associated with the infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments; 5. Known active HIV infection (i.e. HIV1/2 antibody positive); Untreated active HBV (defined as HBsAg/HBcAg positive with HBV-DNA copy number greater than the upper limit of normal in the laboratory of the research center) and HCV infection (HCV antibody positive with HCV-RNA levels above the upper limit of normal); 6. Merge uncontrollable systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial disease, and other cardiovascular diseases; Uncontrollable hypertension (defined as systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg after standardized antihypertensive treatment), or a history of critical hypertension, hypertensive encephalopathy; Uncontrollable diabetes, etc; 7. There are serious gastrointestinal diseases (including active bleeding, obstruction greater than grade 1, diarrhea greater than grade 1, or gastrointestinal perforation) present; 8. History of cesarean section, open chest surgery, or intestinal resection within 28 days prior to enrollment; 9. Presence of interstitial pneumonia or pulmonary fibrosis; 10. Known to be allergic or intolerant to therapeutic drugs or their excipients; 11. History of pulmonary hemorrhage/hemoptysis >= grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to enrollment; Within the 6 months prior to enrollment, there is a tendency for arterial embolism, severe bleeding (excluding bleeding caused by surgery), or existing embolism or severe bleeding; 13. Existence of central nervous system metastasis; 14. Patients with serum albumin <= 3 g/dL; 15. Those who use strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1; 16. Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial; 17. Those who have participated in other studies within 30 days prior to the administration of the first dose of the investigational drug; 18. Patients allergic to bevacizumab, irinotecan, fluorouracil, calcium folinate, and compound gossypol acetate tablets; 19. The researcher determines that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;CBR;DoR;TTR;OS;AE; | — |
Countries
China
Contacts
Public ContactGuiying Wang
The Second Hospital of Hebei Medical University
Outcome results
None listed