Advanced gynecological tumor
Conditions
Interventions
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. For women aged 18-70, the expected survival time is not less than 3 months; 2. Patients with advanced, locally advanced or recurrent gynecologic tumors confirmed by histology or cytology (including but not limited to ovarian cancer, endometrial cancer, cervical cancer, etc.); 3. Patients who failed in previous standard treatment, or who gave up treatment for various reasons after first-line treatment failed; 4. Patients with EGFR gene mutation or ALK gene rearrangement developed disease progression or toxicity intolerance after first-line TKIs treatment; 5. Patients who failed to receive PD-1 or PD-L1 antibody treatment or stopped the treatment for more than 4 weeks; 6. Patients with at least one measurable target lesion (RECIST v1.1); 7. Patients with ECoG score of 0-2; 8. Patients who provide tumor tissue with initial or recurrence and can cut at least 8 sections for staining and detection. 9. Routine blood examination: white blood cell count (WBC) >= 3 x 10^9 / L, lymphocyte percentage (ly%) >= 15%, hemoglobin (HB) >= 90g / L, platelet (PLT) >= 60 x 10^9 / L; 10. Liver and kidney function: alanine aminotransferase, aspartate aminotransferase (alt, AST) < 3 times of normal value, total bilirubin (TBIL) < 1.5 times of normal value, serum creatinine (SCR) < 1.5 times of normal value; 11. Patients whose expression of mesothelin antigen was more than 50%; 12. The patients who volunteered to join the study signed informed consent with good compliance and cooperated with follow-up, 13. Patients who received radiotherapy and chemotherapy more than 4 weeks apart.
Exclusion criteria
Exclusion criteria: 1. Subjects with HBsAg or HBcAb positive and HBV DNA titer >= 5 x 10^2 copies / L in peripheral blood; subjects with HCV antibody positive and HCV RNA positive in peripheral blood; subjects with HIV antibody positive; subjects with CMV DNA positive; subjects with syphilis positive; 2. Patients who have received any gene therapy before; 3. Patients who need long-term use of immunosuppressants for any reason; 4. Patients with any serious, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis, etc; 5. Subjects with severe heart, lung, liver and kidney dysfunction or patients with severe weakened lung disease; heart function: Grade 3 or above according to the New York Heart Association (NYHA) standard; liver function: Grade C or above according to the child Puge classification standard; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; lung function: symptoms of severe respiratory failure, including Other organs; brain function: central nervous system abnormalities or disturbance of consciousness; uncontrolled brain metastasis. 6. Patients who are currently using steroids (except those who have recently or are currently using inhaled steroids); 7. Pregnant and lactating subjects (the safety of this therapy for unborn children is not clear, and the study participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before injection); 8. Patients allergic to immunotherapy and related drugs; 9. Subjects with history of organ transplantation or waiting for organ transplantation; 10. After evaluation, the researcher believes that the subjects are unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactJianjun Xiao
Zhongshan People's Hospital
Outcome results
None listed