Gestational Trophoblastic Neoplasia
Conditions
Interventions
single:EMA/EP
even:TP/TE
Sponsors
The Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study and signed an informed consent; 2. The GTN diagnostic criteria in the 2018 FIGO Cancer Report; 3. Previously received EMA/CO regimen chemotherapy and have any of the following conditions: (1) Resistance to EMA/CO regimen: It is defined as the detection of blood ß-hCG level every 2 weeks, and hCG is maintained at a plateau (change 10%). When the blood hCG is higher than that before treatment or before the change of the regimen 2 weeks after treatment or 2 weeks after the replacement of the new regimen, it is not considered as drug resistance; (2) Disease progression during treatment with EMA/CO regimen: It is defined as physical examination or imaging examination suggesting new metastases; (3) Recurrence: GTN patients who have been treated with EMA/CO regimen to achieve complete remission (defined as hCG dropped to the normal range and maintained for more than 1 month) have increased hCG again, with or without imaging examination suggesting space-occupying Lesions, pregnancy, pituitary hCG and other conditions are excluded after systematic examination; (4) Treatment failure: partial remission (defined as hCG decreased to less than 200mIU/mL and maintained for more than 3 months; or hCG decreased to normal level but increased again within 1 month) after partial remission (defined as hCG decreased to a normal level but increased again within 1 month) after previous treatment with EMA/CO regimen. Continuously elevated hCG or imaging suggests the appearance of new lesions or metastases; 4. ECOG score 0~1; 5. The functions of important organs meet the following requirements: Absolute neutrophil count >=1.5x10^9/L; Platelets >=90x10^9/L; Hemoglobin >=90 g/L; Serum albumin >=30 g/L; Bilirubin<=1.5 ULN; ALT and AST <=3 ULN; if there is liver metastasis, ALT and AST<5 ULN; Serum creatinine <=1.5 ULN.
Exclusion criteria
Exclusion criteria: Any of the following cannot be included in this study: ?. The pathological diagnosis is PSTT or ETT; ?. Past (within 5 years) or at the same time suffering from other uncured malignant tumors, cured skin basal cell carcinoma Except for cervical carcinoma in situ and breast carcinoma in situ; ?. After the diagnosis of GTN, they have received combination chemotherapy or platinum-containing chemotherapy; ?. Active infection, unexplained fever =38.5? within 7 days before randomization, or baseline leukocyte count Number>15×109/L; ?. Patients with congenital or acquired immune deficiencies (such as HIV infection); ?. Those who are known to be allergic to any study drugs or excipients; ?. Judging by the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory abnormalities , Accompanied by family or social factors, it will affect the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hCG; | — |
Countries
China
Contacts
Public ContactLu xin
The Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed