ovarian cancer
Conditions
Interventions
Experimental group:Paclitaxel for injection (albumin-bound)
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients aged between 18 to 75 years old; 2) Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; 3) Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen; 4) Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria; 5) Eastern Cooperative Oncology Group (ECOG) status 0-2; 6) Expected survival = 3 months; 7) Bone marrow function: Neutrophils = 1.5×10^9/L, platelets = 100×10^9/L, hemoglobin = 90 g/L; 8) Hepatic and renal function: Serum creatinine = 1.5×ULN; AST and ALT = 2.5×ULN or = 5×ULN in the presence of hepatic metastasis; Total bilirubin = 1.5×ULN, or = 2.5×ULN in patients with Gilbert's syndrome; 9) Must agree to use effective contraception during the trial, women of childbearing potential must have a negative serum or urine pregnancy test; 10) Non-lactating patients; 11) Signing informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have been treated with albumin-bound paclitaxel; 2) Patients who have received abdominal or pelvic radiotherapy; 3) Patients with central nervous system disease or brain metastases; 4) Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured; 5) Prior Grade = 2 sensory or motor neuropathy; 6) Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 7) Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients; 8) Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy; 9) Serious infections occurred within 4 weeks prior to the start of the study, including but not limited to infection complications, bacteremia or severe pneumonia requiring hospitalization; 10) Patients with HIV (human immunodeficiency virus) positive; 11) Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer detection of = 1 × 10^3 IU / mL of the subject; if HBsAg positive, and peripheral blood HBV-DNA <1 × 10^3 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; 12) Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive, and HCV RNA test positive; 13) Patients not suitable for participation in this study judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free Survival;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactZhao Jun
Changzhi People's Hospital
Outcome results
None listed