Gynecologic Carcinoma
Conditions
Interventions
Experimental Group:SHR-1210 combined with Apatinib
Sponsors
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be willing and able to provide written informed consent/ for the trial. 2. Women aged 18-75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of =1.5 *10^9/L; Hb >= 90g/L; Plt>= 75 * 10^9/L; Serum albumin >= 30g/L TBIL = 60mL/min. 10. Female Subjects of childbearing potential must have a negative serum/urine pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception (IUD, oral contraceptive or condom) for the course of the study through 3 months after the last dose of study treatment. Not in lactation period.
Exclusion criteria
Exclusion criteria: 1. Patients with a prior invasive malignancy who have had any evidence of disease within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Patients with metastatic gynecologic carcinoma, such as Krukenberg tumor. 2. Participated in other clinical trials within 4 weeks. Prior exposure to immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies, or prior exposure to VEGFR inhibitor. Patients who may receive live vaccine within 4 weeks. 3. Patient has known active central nervous system (CNS) metastases: if who previously treated brain metastases and/or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment. The time from the last brain radiotherapy is at least 4 weeks prior to trial treatment. If patient has brain metastasis without obvious CNS symptoms , the time from the last brain radiotherapy is at least 1 week prior to trial treatment. 4. Patients with bone metastases received palliative radiotherapy more than 5% of the bone marrow area within 4 weeks before the study. 5. Clinically significant diseases, including but not limited to heart failure, respiratory failure, hepatorenal insufficiency. Acute or uncontrolled severe infection. Non-union of chronic wound or fracture. Patients with any active autoimmune disease. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease. Hepatitis B virus (HBV) > 2000 IU/ml or DNA >= 1 * 10^4/ml; or hepatitis C virus (HCV) RNA >= 1 * 10^3/ml). 6. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg. 7. Coagulation abnormalities (PT>16s, APTT>43s, TT>21s, Fbg= (++) and 24 hours total urine protein > 1.0 g. 10. Prior chemotherapy, radiotherapy, homone therapy, surgery therapy, or molecular targeted therapy within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1. 11. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective tumor response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective tumor response rate;disease control rate;progression free survival;overall survival;objective tumor response;duration of disease control; | — |
Countries
China
Contacts
Public ContactWeiwei Feng
Department of Obstetrics and Gynecology, Ruijin Hospital affiliated to Shanghai Jiaotong University, School of Medicine
Outcome results
None listed