Platinum-resistant / refractory Ovarian Cancer
Conditions
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who signed the informed consent form (ICF) with date according to related laws and guidance in prior to any clinical study related progress instead of daily medical care; 2. Patients failed in second-line treatment or higher, and platinum-resistant ovarian cancer with ascites; 3. Aged 18 - 70 years; 4. Diagnosed as ovarian cancer with solid histology evidence; 5. ECOG evaluation between 0 to 1; 6. With metastatic focus inside peritoneal cavity according to PET-CT, CT, MRI and/or surgery; 7. With appropriate organ functions according to laboratory measurement below: neutrophil count >= 1.5x10^9/L, platelet count >= 75x10^9/L, TBIL <= 1.5 UNL, AST <= 2 UNL, ALT <= 2 UNL, Cr <= 1.5 UNL; 8. Urine or blood pregnancy test negative 7 days before the treatment in women of reproductive age; 9. Estimated survival time longer than 3 months; 10. Patients willing to provide peripheral blood of 50ml or higher, in order to prepare CAR-T immunocytes required for the treatment.
Exclusion criteria
Exclusion criteria: 1. With previous or concurrent other active cancer (except carcinoma in situ that has been cured without onset within 5 years, or those can be cured by adequate treatment); 2. Patients with metastasis to Central Nervous System or brain; 3. APTT or PT >= 5 UNL, or with bleeding evidence in two months or bleeding history in prior to the clinical study, no matter how serious it is; 4. Active inflammation within 7 days after systemic antibiotics treatment; 5. Active coronary artery disease, serious or unstable angina pectoris, or newly diagnosed angina pectoris or myocardial infarction within 12 months in prior to the clinical study; 6. Thrombosis or embolism event within 12 months in prior to the clinical study, such as cerebrovascular accident ( including TIA) or pulmonary embolism; 7. Congestive heart failure of NYHA >= Class II; 8. HIV infected or known AIDS, or active hepatitis (HBV defined as HBV-DNA >= 500 IU/ml, HCV defined as HCV-RNA >= ULN) or concurrent inflammation of HBV and HCV or other virus without treatment; 9. Any existed active known or suspected immune disease; 10. Any interstitial lung disease, noninfectious causes of lung inflammation, or uncontrolled systemic disease (e.g. diabetes, pulmonary fibrosis, or acute pneumonia); 11. Any adverse event of CTCAE (Ver 5.0) grade 2 or higher induced by previous treatment; 12. Received PD-1 or anti-PD-L1, anti-CTLA-4 or other drugs targeting T cell co-stimulation channel drug or antibody in the history; 13. Pregnant or lactating women, or those show positive in pregnancy test before 1st injection; 14. Any conditions that researchers consider inappropriate for the clinical studies; 15. With serious psychological abnormalities; 16. Joined other clinical trials in four weeks prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcome; | — |
Countries
China
Contacts
Public ContactZhu Jianqing
Zhejiang Cancer Hospital
Outcome results
None listed