Intermediate trophoblastic tumors
Conditions
Interventions
QL1706 treatment group:QL1706
QL1706 and chemotherapy group:QL1706 plus chemotherapy
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Females aged 18-70 years old; 2. Pathological diagnosis of PSTT or ETT; 3. Cohort A: patients with stage IV treatment, relapse or chemotherapy resistance; Cohort B: high-risk patients with stage I-III disease who underwent biopsy or postoperative chemotherapy and met one of the following criteria: (1) abnormal HCG at two weeks postoperatively, (2) surgical unresected lesions, (3) high-risk factors (interval between previous pregnancies>=48 months, deep myometrial invasion, mitotic image>5/HPF, necrosis); 4. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0-1; 5. Voluntarily sign the informed consent form; 6. Good function of major organs;
Exclusion criteria
Exclusion criteria: 1. Estimated survival time10mg daily prednisone equivalent) or other immunosuppressive drugs is required within 14 days of enrollment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalent are permitted. Physiologic replacement doses of systemic corticosteroids are permitted. 8. Known history of human immunodeficiency virus or known positive test for acquired immunodeficiency syndrome; 9. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA > 1000 IU/mL, and patients with active hepatitis C should be excluded. Carriers of inactive hepatitis B surface antigen (HbsAg), treated and stable hepatitis B patients (HBV DNA < 1000 IU/mL), and cured hepatitis C patients may be enrolled. 10. Known to have active tuberculosis (TB). Subjects with suspected active TB should have a chest x-ray, sputum, and exclusion by clinical signs and symptoms. 11. Have severe active infection requiring systemic treatment, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia. 12. Uncontrolled cardiovascular disease, including: (1) symptomatic congestive heart failure (grade 3 or 4 determined by the New York Heart Association), or left ventricular ejection fraction (LVEF) of <50% on cardiac ultrasound. (2) Uncontrolled hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg despite optimal medical therapy). (3) Poorly controlled arrhythmias. (4) Evidence of unstable angina, acute or ongoing myocardial ischemia. 13. Any arterial thromboembolic event, including myocardial infarction, cerebrovascular accident or transient ischemic attack, within 6 months prior to enrollment, and a history of deep vein thrombosis, pulmonary embolism or any other severe thromboembolism. 14. Known presence or history of interstitial lung disease. 15. Factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction. or cavity viscular sinus tract or perforation within 6 months. Severely active peptic ulcer disease or gastritis. 16. Mental illness and social conditions that will restrict the subject's compliance with the requirements of the study or affect the subject's ability to provide written informed consent; 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 18. Received a live vaccine within 30 days prior to the first dose of QL1706, or plans to receive a live vaccine during the study; 19. Known history of severe hypersensitivity reactions to other monoclonal antibodies and chemotherapy drugs required for research; 20. Pregnant or lactating females; 21. Any condition that, in the opinion of the investigator, may harm the subject or cause the subject to be unable to meet or perform the requirements of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| diseaase control rate;life quality;progress free survival;?Objective Response Rate;treatment related adverse effects;overall survival;duration of response;Ovary function; | — |
Countries
China
Contacts
Public ContactXiang Yang
Peking Union Medical College Hospital
Outcome results
None listed