Gynecological malignancies
Conditions
Interventions
Gold Standard:RECIST 1.1 criteria
Index test:RecistTM criteria
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? The Informed Consent Form (ICF) was fully understood and voluntarily signed for this study; ? Age: 18 ~75 years old; ? Patients with cervical, ovarian, or endometrial cancer with histological and / or cytology confirmed stage III – IV without indication for surgery; ? At least one measurable lesion (according to RECIST 1.1); ? Before treatment, any one of the main tumor markers was higher than three times the normal level. The main tumor markers included: CA125>105U/ml, HE4>223pmol/ml, CEA>15ng/ml, CA199>81 U/ml, SCCAg>8.1ng/ml; ? The performance status score was 0 or 1 by the Eastern Cooperative Oncology Group (ECOG) criteria; ? Expected survival time = 3 months; ? Good organ function: 1) Routine blood examination: (no blood transfusion, no use of G-CSF, and no drug correction within 14 days before screening the first month of the lunar year): • Hemoglobin (HB)=90 g/L; • Absolute Neutrophil Count (ANC)=1.5×10^9 /L; • platelet count (PLT)=100×10^9 /L; • leucocyte count=4.0×10^9 /L Or the lower limit of normal values at this study site, and=15×10^9 /L; 2)Biochemical examination: (no blood transfusion or albumin within 14 days prior to screening) • AST ALT=1.5 x ULN(If there is tumor liver metastasis, =5 x ULN); • ALP=2.5 x ULN(If there is tumor bone metastasis, =5 x ULN); • TBiL=1.5 x ULN; • ALB=30 g/L; • Cr=1.5 x ULN,meanwhile,creatinine clearance rate (CrCL)=60 mL/min(cis-platinum complexes) CrCL =50 mL/min(carboplatin)(The Cockcroft-Gault formula); APTT=1.5 x ULN, meanwhile, INR or PT=1.5 x ULN(no anticoagulation treatment was received); ? Female fertility must have a negative serum pregnancy test within 7 days before the first dose and be willing to adopt effective birth control / contraceptive methods during the study period until 6 months after the last dose of the study; ? Willing and able to comply with the study plan visits, treatment plans, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: ? Subjects with active or recurrent autoimmune disease; ? Severe active infections, including but not limited to tuberculosis or human immunodeficiency virus (HIV) (HIV 1 / 2 antibody positive); ? Subjects with known severe or uncontrolled underlying disease; ? Current pregnancy period (confirmed by positive pregnancy test results) or lactation period; ? Excluding subjects with other active malignancies requiring concurrent treatment; ? Subjects with mental illness, alcohol abuse, drug use, or substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tmCR;tmPR;tmPD;tmSD; | — |
Secondary
| Measure | Time frame |
|---|---|
| tmPFS;Consistency;Accuracy;tmOS; | — |
Countries
China
Contacts
Public ContactYANG YI
Army Medical Center of PLA
Outcome results
None listed