recurrent and refractory ovarian cancer
Conditions
Interventions
One arm intervention group:Anlotinib+CART
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The age ranged from 18 to 70 years old; (2) The expected survival time was more than 12 weeks; (3) ECoG score was 0-2; (4) Relapsed and refractory ovarian cancer with poor effect after receiving 2-line or above standard treatment in the past (without remission or recurrence after remission); (5) According to RECIST standard 1.1, there should be at least one measurable tumor focus; (6) The expression of mesothelin was positive in tumor tissues; (7) The absolute neutrophil count was more than 1000 / UL; (8) The absolute count of lymphocyte was more than 0.7 x 10^9 / L; (9) Platelet count >= 75000 / UL; (10) The liver and kidney function, heart and lung function meet the following requirements: a) Creatinine was in the normal range; b) LVEF > 50%; c) Baseline blood oxygen saturation > 92 %; d) Total bilirubin <= 2 x ULN; ALT and AST <= 2.5 times the upper limit of normal value; (11) The venous access for collection can be established, and mononuclear cells can be collected according to the judgment of researchers; (12) Those who can understand the experiment and have signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) In the 5 years before screening, they had malignant tumors other than ovarian cancer except for cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and ductal carcinoma in situ after radical operation; (2) The subjects with positive HBsAg or HBcAb and HBV DNA titer >= 1 x 10^2 copies / L, HCV antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus (HIV) antibody positive, CMV DNA positive, syphilis positive, and so on; (3) Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; other disorders Any uncontrolled active disease that hinders participation in the trial; (4) The central nervous system was invaded; (5) Any situation that the researcher thinks will damage the safety of the subject or interfere with the purpose of the study; (6) Pregnant or lactating, or planning pregnancy during or after treatment; (7) There were active or uncontrollable infections requiring systemic treatment 14 days or 14 days before enrollment; (8) The researcher considered that it was not suitable to participate in the experiment; (9) Patients who had received car-t therapy or other gene modified cell therapy before screening; (10) Those who are affected by the illness and sign written informed consent or are unable to comply with the research procedures; those who are unwilling or unable to comply with the research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; | — |
Countries
China
Contacts
Public ContactJuemin Fang
Shanghai Tenth People's Hospital
Outcome results
None listed