Cervical cancer
Conditions
Interventions
The experimental group:Doxorubicin hydrochloride liposome injection combined with cisplatin
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged >= 18 years; 2) Histologically confirmed as cervical squamous cell carcinoma and adenocarcinoma,stages IB2-IIA2(According to FIGO 2009), and without previous treatment; 3) with measurable disease according to RECIST 1.1; 4) Had never received radiotherapy or chemotherapy before; 5) ECOG = 50%; 7) Expected survival >= 3 months; 8) Bone marrow function: neutrophils >= 1.5 x 10^9/L, platelet >= 100 x 10^9, 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;Total bilirubin <= 1.5 times the upper limit of the normal value, or <= 2.5 times the upper limit of the normal value if the patient has Gilbert's syndrome; 10) Women of childbearing age must use adequate contraception during the study period,whose blood or urine pregnancy tests were negative,and are non-lactation; 11) Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis; 2) Patients with congenital diseases or infectious diseases; 3) Have been diagnosed with New York Heart Association (NYHA) grade II or above heart disease, or congestive heart failure; 4) Uncontrolled severe medical conditions which may affect the treatment compliance of the study, such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,Uncontrolled infection, active peptic ulcer, etc. 5) Known allergic, highly sensitive or intolerant to the studied drugs or their excipients; 6) Patients with CNS disease or CNS metastases; 7)Receive other chemotherapy drugs within 30 days before the first study chemotherapy; 8) Other conditions considered to be inappropriate to be enrolled by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactMeng Yuanguang
Chinese People's Liberation Army General Hospital
Outcome results
None listed