cervical cancer
Conditions
Interventions
Case series:Albumin Paclitaxel
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Female, aged 18 to 70 years; 2) Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma diagnosed by histopathology; 3) Pathologically diagnosed with stage IVb, recurrent or metastatic cervical cancer, who have not received chemotherapy for recurrent or metastatic cervical cancerin the past; this recurrence and metastasis have been assessed that cannot undergo surgery/radiotherapy or the patient refuses surgery/radiotherapy; 4) at least one measurable lesion according to RECIST 1.1; 5) ECOG score=3 months; 7) Bone marrow function: white blood cells >=3x10^9/L, neutrophils >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=90g/L; 8) Liver and kidney function: total bilirubin (TBIL) <=1.5 ULN, alanine aminotransferase (ALT), aspartate aminotransferase (AST) <=2.5 ULN; if due to liver metastasis, the above indicators <=5 ULN; serum creatinine (Cr) <=1.5 ULN 9) child-bearing women have a negative pregnancy testand agree to take effective contraceptive measures during the study period and within 1 years after the last administration; 10) written informed consent before the study.
Exclusion criteria
Exclusion criteria: 1) Patients who participated in other clinical trials or received other anti-tumor treatments within 28 days before starting treatment, including but not limited to chemotherapy, radiotherapy or targeted therapy; 2) Peripheral neuropathy of grade II and above within 28 days before enrollment; 3) Known to be allergic or intolerant to chemotherapy drugs or their adjuvants; 4) Severe systemic infection; 5) Important organ disorders or diseases: liver and kidney dysfunction, myocardial infarction, unstable heart disease, chronic active hepatitis, etc.; 6) Ascites requiring drainage or diuretic treatment, or pleural fluid or pericardial effusion that requires drainage and/or shortness of breath within 14 days before the first study drug treatment; 7)Patients with bilateral hydronephrosis or hydroureterosis (after pyelostomy or ureteral stent implantation, at least one side of the hydronephrosis and ureter relief can be selected); 8) Symptomatic brain metastasis or spinal cord compression; For patients with brain metastases who have received previous treatment, if the clinical condition is stable within 28 days before the first study drug treatment and the imaging evidence does not show the disease progression, they can be considered for inclusion; 9) Any medical condition in which the investigator believes that the patient is not suitable for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactXiaofan Li
Beijing Cancer Hospital
Outcome results
None listed