Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03563326
Other study ID # WCH-GC-CART
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 30, 2018
Est. completion date December 31, 2022

Study information

Verified date September 2018
Source West China Hospital
Contact Jian-Kun Hu, M.D. Ph.D.
Phone 02885422878
Email hujkwch@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Chimeric antigen receptor modified T (CAR-T) cells have the capability in targeting and recognizing tumor antigen, and can specifically recognize, bind and kill tumor cells with positive antigen. Through local drug delivery, CAR-T cells have successfully achieved remarkable effect to treat solid tumors. Gastric cancer is one of the most frequent malignant tumors with high mortality, especially in China. Peritoneal metastasis is one of the common routes of metastasis. Once peritoneal metastasis occurred, patients should be categorized as clinical pathological stage IV with extremely poor prognosis, and the effect of routine treatments would be unsatisfactory. Epithelial cell adhesion molecule (EpCAM) is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients. In our previous pre-clinical research researches, the investigators have obtained CAR-T cells targeting EpCAM (EpCAM CAR-T), and finished the preparations of cells which could be used in clinical practice. Based on our previous works, the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
CAR-T cells targeting EpCAM
Biological: CAR-T cells targeting EpCAM
Chemotherapy
Chemotherapy: determined by medical Oncologist

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Jian-Kun Hu

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT00065117 - Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer. Phase 2
Completed NCT00039780 - Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel Phase 3
Terminated NCT00048893 - Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT00037869 - High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors Phase 3
Completed NCT02265549 - Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases N/A
Completed NCT00034918 - This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer Phase 2
Completed NCT01115751 - A Study in Patients With Advanced or Metastatic Cancer Phase 1
Terminated NCT01115803 - A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors Phase 1
Completed NCT00056173 - Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma Phase 1/Phase 2
Recruiting NCT05419518 - Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas Phase 2
Terminated NCT00034697 - Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143) Phase 2
Completed NCT00055471 - A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer Phase 2
Completed NCT00046514 - ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer Phase 2
Completed NCT00046527 - Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer Phase 3
Completed NCT00041808 - Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver Phase 1/Phase 2
Completed NCT00037609 - Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients Phase 1/Phase 2
Withdrawn NCT00038038 - Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole N/A
Completed NCT03670992 - Surgical Treatment of Pancreatic RCC Metastases
Terminated NCT00050336 - Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED) Phase 3
Completed NCT00044863 - Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma Phase 2