Metastases, Neoplasm Clinical Trial
Official title:
Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Patients with EpCAM positive gastric cancer who have peritoneal metastasis at first visit; Patients with highly suspected or previous proven peritoneal metastasis by biopsy, CT, digital rectal examination, etc. who failed to the routine therapies like chemotherapy; 2. Age between 18 and 75; 3. Estimated survival time is longer than 3 months; 4. Eastern Cooperative Oncology Group (ECOG)scores 0-2; 5. Hemoglobin=90g/L, ANC=1.5×109/L, PLT=80×109/L; 6. Negative pregnancy test for child-bearing period; both male and female patients should agree to apply effective contraceptive methods in the period of treatment and one year after treatment; 7. Both patients and families totally understand the objectives and risks of the treatments and sign the informed consent. Exclusion Criteria: 1. Comorbidity with other diseases treated by immunosuppressive drugs or steroids therapy systematically; 2. Uncontrolled active infection; 3. HIV positive; 4. Active hepatic B or C virus infection, active tuberculosis; 5. Pregnant or lactation female; 6. Disagree to apply effective contraceptive methods in the period of treatment and one year after treatment; 7. Positive cytology examination alone. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Jian-Kun Hu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EpCAM CAR-T cells treatment related adverse events | Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0. | 4 weeks | |
Secondary | Overall survival outcome | 2-year overall survival rate | 2 years | |
Secondary | Metabolism kinetics of CAR-T cells | The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry. | 2 years | |
Secondary | Progress free survival outcome | 2-year progress free survival | 2 years |
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