ovarian cancer
Conditions
Interventions
experimental group: paclitaxel (albumin-binding) combined with carboplatin
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 yearsfemale; 2. Histopathologically confirmed patients with FIGO stage III or FIGO stage IV epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer; 3. Conforms to the new auxiliary indications for ovarian cancer: (1) patients with stage III-IV ovarian cancer who are considered to be unlikely to reach R0 by gynecologic oncologists before surgery; (2) patients who are not suitable for surgery; 4. Have at least 1 measurable lesion (RECIST version 1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 6. Pathologically confirmed after R0 resection of pancreatic adenocarcinoma; 7. Estimated survival time >12 weeks; 8. Bone marrow function: neutrophils >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin>=90g/L; 9. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and ALT <= 2.5 times the upper limit of normal value or <= 5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin <= 1.5 times the upper limit of normal value, or patient <= 2.5 times the upper limit of normal value when there is Gilbert's syndrome; 10. Subjects of childbearing age must agree to take effective contraceptive measures during the trial; pregnant women with serum or urine pregnancy test must be negative; 11. Non-lactating patients; 12. Agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with clinically significant cardiovascular disease; 2. Except for any malignant tumors that have been treated with anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy) or have occurred in the past 5 years, except for cured cervical cancer in situ and non-melanoma skin cancer; 3. Patients with central nervous system diseases or brain metastases; 4. Gradual >= 2 sensation or motor neuropathy occurred in the past; 5. The investigator believes that it will affect the subject's ability to receive research protocols and uncontrolled serious medical conditions, such as severe medical illness, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection, activity Peptic ulcer, etc.; 6. It is known to be allergic, highly sensitive or intolerant to research-related drugs or their excipients; 7. Studying serious infections within 4 weeks prior to the start of treatment, including but not limited to infection complications, bacteremia or severe pneumonia requiring hospitalization; 8. 7 days prior to receiving the study drug, diagnosed as an immunodeficiency disease or receiving systemic steroid therapy or other immunosuppressive therapy; 9. AIDS antibody (HIV-AG/AB) test results are positive; 10. Hepatitis B surface antigen positive (HBsAg), and subjects with peripheral blood hepatitis B virus DNA (HBV-DNA) titer >= 1x10^3IU / mL; if HBsAg is positive, and peripheral blood HBV-DNA < 1x10^3 IU/mL, if the investigator believes that the subject's chronic hepatitis B is in a stable phase and does not increase the risk of the subject, the subject is eligible for inclusion; 11. Hepatitis C virus (HCV) antibody test results are positive; 12. The investigator judged patients who were not eligible to participate in the study. Note: At screening, the investigator should ensure that the subject meets all inclusion criteria. Subjects should be excluded from the trial if the subject's condition changes (including laboratory findings) after screening but has not been administered to the first study drug and the exclusion criteria are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I: Probability and severity of adverse reactions;Phase II: R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Outcome results
None listed