Recurrent Platinum resistance or refractory Ovarian Cancer
Conditions
Interventions
experiment group:PD-1 antibody deactivated autologous T lymphoid cells
Sponsors
The Third Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Those who agreed to participate in the trial and signed a written informed consent. 2. Female, aged over 18 and under 75 (including 18 and 75). 3. The patients whose expected survival time is more than 3 months can be followed up. 4. Patients with ovarian cancer confirmed by histology / cytology and imaging, and at least one measurable lesion according to RECIST 1.1. 5. According to recist1.1 criteria, the researchers evaluated the images from at least two pre-trial imaging examinations with diagnostic quality, and identified the subjects as platinum resistant ovarian cancer (progression or recurrence within 6 months after the initial platinum based chemotherapy), or platinum resistant ovarian cancer (progression during the last platinum based chemotherapy or within 4 weeks after the last platinum based chemotherapy). 6. Subjects with ECoG score of 0 or 1 within 7 days before randomization. 7. Within 14 days before the beginning of treatment, the subjects whose blood routine, liver and kidney function and hormone level laboratory examination results meet the following standards: white blood cell (WBC) >= 3.5 x 10^9 / L, platelet (PLT) >= 100 x 10^9 / L, neutrophil (ANC) >= 1.5 x 10^9 / L, hemoglobin (Hgb) >= 90g / L, aspartate aminotransferase (AST) 30Gy, they must recover from the toxicity or complications of these interventions, that is, they can still be enrolled after 6 months. 9. Female subjects must take effective contraceptive measures during the whole study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
Exclusion criteria
Exclusion criteria: 1. Subjects with platinum sensitive and partially platinum sensitive ovarian cancer. 2. Patients with known disease progression or other malignant tumors requiring active treatment. Exceptions include early stage tumors (carcinoma in situ or stage I tumors) that have received radical treatment, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma of the cervix in situ or carcinoma of the breast in situ that have received potentially radical treatment. 3. Patients who have received allogeneic tissue / organ transplantation. 4. Subjects receiving systemic sex hormone therapy or any other form of immunosuppressant therapy within 3 days before the first administration of experimental treatment. 5. Patients who had received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the study drug; patients who had received radiotherapy of more than 30Gy within 6 months before the first use of the study drug; patients who had received radiotherapy of 30Gy or less within 7 days before the first use of the study drug. 6. Patients who have received other PD-1 antibody therapy and other immunotherapy for PD-1 / PD-L1. 7. Patients with active autoimmune diseases requiring systemic treatment (such as use of disease relief drugs, corticosteroids or immunosuppressants) in the past two years. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) does not belong to systemic therapy. 8. Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10 ^ 3 copies / ml) or hepatitis C (HCV antibody positive), and HCV-RNA higher than the detection limit of the analysis method. 9. Subjects who received live vaccine within 4 weeks before the first use of the study drug were allowed to receive inactivated virus vaccine for seasonal influenza, but not live attenuated influenza vaccine for nasal use. 10. Subjects with known active central nervous system (CNS) metastasis and / or cancerous meningitis. Subjects with brain metastases can also participate in this study as long as they are in stable condition (confirmed by MRI before the first administration, no evidence of progression for at least 4 weeks, and all neurological symptoms have returned to baseline level), no evidence of new or expanded brain metastases, and have not received hormone therapy for at least 3 days before the study administration. 11. Patients with active infections requiring intravenous systemic therapy. 12. Patients with mental illness or other conditions, such as uncontrollable heart or lung disease, diabetes, etc., can not cooperate with the requirements of research treatment and monitoring. 13. Patients known to be allergic to any of the components of the study drug. 14. Subjects who regularly use any drug (including "recreational" use) or who have a recent history of drug abuse (including alcohol) (within one year) at the time of signing the informed consent. 15. Subjects with poor compliance can not cooperate with clinical research. 16. Female subjects who were pregnant or breastfeeding or expected to be pregnant during the trial period (from the screening visit to 180 days after the last administration).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of Response;Quality of life improvment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactPing Yi
The Third Affiliated Hospital of Chongqing Medical University
Outcome results
None listed