Ovarian cancer
Conditions
Interventions
Experimental group:Fruquintinib combined with azithromycin liposome
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 75 years; 2. Patients diagnosed with epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer by histopathology (except low-grade serous, mucinous, clear cell carcinoma); 3. Platinum-resistant patients with disease progression within 6 months after the end of the previous platinum-containing chemotherapy or during platinum-containing chemotherapy; 4. At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1; 5. Physical performance status score (ECOG)= 3 months; 7. The toxicity of previous anti-tumor therapy has recovered to =1.5x10^9/L; 2) Platelets>=75x10^9/L; 3) Hemoglobin>=90g/L; 4) Serum creatinine =3.0 g/dL; (2) Coagulation function: prothrombin time (PT), international normalized ratio (INR) <= 1.5x ULN. 9. Female subjects with negative urine or blood HCG (except menopause and hysterectomy), female subjects of childbearing age and their partners take effective contraceptive measures during the trial and within 6 months after the end of the last medication (for example: combined hormones (including estrogen and progesterone) combined with ovulation inhibition, progesterone contraception combined with ovulation inhibition, intrauterine device, intrauterine hormone releasing system, bilateral tubal ligation, vasectomy, sex avoidance, etc.); 10. No second tumor in the past 5 years, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part; 11. Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with ovarian tumors of low malignant potential; Suffering from other malignant tumors within 2.5 years, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part; 3. Uncontrolled serious medical diseases that the investigator believes will affect the subject's ability to receive treatment with the research program, such as combined serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled infection, etc.; 4. The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; or Those who have gastrointestinal perforation or gastrointestinal fistula and have not recovered after surgical treatment; 5. Patients with evidence of bleeding tendency or medical history (such as melena, hematemesis, hemoptysis, bloody stool, etc.) within 2 months before the first medication; 6. During screening, it was found that the tumor invaded large vascular structures, such as the pulmonary artery, superior vena cava or inferior vena cava, etc., and the investigator judged that there was a greater risk of bleeding; 7. History of arterial thrombosis or deep venous thrombosis within 6 months before the first medication; or a stroke event and/or transient ischemic attack within 12 months; due to implantable venous infusion pump or catheter-derived thrombosis or superficial venous thrombosis, except for those with stable thrombus after conventional anticoagulation therapy; 8. Known to be allergic, highly sensitive or intolerable to research-related drugs or their excipients; 9. Receive other investigational drug chemotherapy, targeted, immunotherapy, clinical trials, etc. within 4 weeks of the first chemotherapy administration; 10. Pregnant or lactating female patients; subjects of childbearing age who refuse to accept contraceptive measures; 11. Have any other diseases, metabolic disorders, physical examination results or abnormal laboratory test results, and have reason to suspect that the use of experimental drugs may be contraindicated, or diseases or conditions that affect the reliability of research results; 12. Previous use of anti-angiogenesis drugs or liposomal doxorubicin, etc.; 13. Patients who are judged by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactLi Guiling
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed