Gynecological malignancies
Conditions
Interventions
Cervical cancer group:PD-1 mAb+S(c)TIL 3-5x10^9
Ovarian cancer group:PD-1 mAb+S(c)TIL 3-5x10^9
Malignant trophoblastic tumor group:PD-1 mAb+S(c)TIL 3-5x10^9
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, female; 2. Expected survival > 3 months; 3. Clinically confirmed advanced gynecological tumors, including cervical cancer, ovarian cancer and malignant trophoblastic tumor; 4. Patients who have received radical surgery plus or minus adjuvant chemoradiotherapy, or who have suffered disease progression or recurrence after receiving excessive line chemoradiotherapy, who have been unable to be surgically resected again or who cannot tolerate chemoradiotherapy; 5. Cervical and ovarian cancer patients with at least one measurable lesion according to RECIST version 1.1; Malignant trophoblastic tumor patients with ßhCG>=5, with or without measurable lesions; 6. Voluntary peripheral blood apheresis ± surgical resection of fresh tumor tissue to obtain cells for cell preparation, and PD-1 positive T cells in peripheral blood accounted for more than 18% of total T cells. For patients who had received PD-1 monoclonal antibody treatment before screening, PD1-positive T cells in peripheral blood accounted for more than 10% of total T cells; 7. The Eastern Oncology Consortium (ECOG) physical status score was 0 to 1; 8. Full bone marrow and organ function: (1) Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) : neutrophil granulocyte count (ANC) >=1.5x10^9, platelet (PLT) >=75x10^9/L, hemoglobin (Hb) >=90g/L, lymphocyte count (LYM) >= 60% lower limit of normal value; (2) Lymphocyte subsets: B lymphocyte (CD19+) accounted for more than the lower limit of normal; (3) Liver function: total bilirubin (TBIL) <=1.5xULN, alanine aminotransferase (ALT) <=3xULN, patients with liver metastasis or liver cancer: <=5xULN, aspartate aminotransferase (AST) <=3xULN, patients with liver metastasis or liver cancer: <=5xULN; (4) Renal function: creatinine <=1.5xULN; (5) Coagulation function: activated partial thromboplastin time (APTT) <=1.5xULN, International Normalized ratio (INR) <=1.5xULN; 9. A fertile woman must agree to use reliable contraceptive methods (hormonal or barrier methods or abstinence, etc.) with her partner permanently during the trial and after medication; Female patients of reproductive age must have had a negative blood or urine pregnancy test within 7 days prior to first use of the study drug; 10. Patients must be informed of this study prior to the study and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or with other evidence that central nervous system metastasis or meningeal metastasis has not been controlled, were judged not suitable for inclusion by researchers; 2. Patients who have a history of a second malignant tumor within 5 years prior to signing the information; 3. Patients who had previously received PD-L1 monoclonal antibody therapy; 4. Patients with active infection within 1 week before apheresis who currently require systemic anti-infection therapy; 5. Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor therapies within 2 weeks prior to apheresis, except for the following: (1) Nitroso-urea or mitomycin C within 6 weeks preharvest; (2) Oral fluorouracil and small-molecule targeted drugs were taken one week before apheresis; 6. Within 2 weeks prior to anapheresis, received systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent dose of the same drug) or other immunosuppressant therapy, except in the following cases: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media); Or used immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc.; 7. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to mono-harvest; Had major organ surgery (excluding needle biopsy) or significant trauma, or required elective surgery during the trial period; Have used live attenuated vaccines; 8. Patients currently suffering from interstitial pulmonary disease; 9. >= Grade 2 irAE after receiving PD-1 monoclonal antibody; >= grade 3 irAE or other immunotherapy; 10. Patients with active or previous autoimmune diseases with potential recurrence (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except clinically stable autoimmune thyroid disease and well-controlled type I diabetes; 11. Previous adverse reactions of antitumor therapy have not recovered to CTCAE level 5.0 evaluation =II or left ventricular ejection fraction (LVEF) < 50%, or have structural heart disease judged by other investigators to be at high risk; (4) Clinically uncontrollable hypertension; 15. Clinically uncontrollable serous cavity effusion, which was judged by the researcher not suitable for inclusion in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ß-human chorionic gonadotropin;Objective response rate;Disease control rate;Duration of response;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXiang Yang
Outcome results
None listed