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Evaluate the Safety and Efficacy of Chimeric Antigen Receptor Engineered T Cell Immunotherapy (CAR-T) in the Treatment of Pancreatic Cancer in a Single Center, Non Controlled Clinical Study.

Evaluate the Safety and Efficacy of Chimeric Antigen Receptor Engineered T Cell Immunotherapy (CAR-T) in the Treatment of Pancreatic Cancer in a Single Center, Non Controlled Clinical Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17012862
Enrollment
Unknown
Registered
2017-10-01
Start date
2017-10-15
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Pancreatic cancer:According to the patient's condition and weight, the intervention dose of aE7 CAR-T cells per kilogram of body weight was treated once.

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Imaging, pathology or biopsy confirmed as pancreatic cancer and it has metastasized, can not radical cured by surgery; patients restored good but there is still residual lesions, recurrence or metastasis 1 months after surgery; 2. Accepted more than 1 times chemotherapy which is invalid or unwilling to accept previous chemotherapy patients; 3. The corresponding antigens such as Meso and PSCA/ CEA/ HER2/ MUC1/ EGFRvIII were highly expressed; 4. Male patients aged between 18 and 65 years; 5. Life expectancy greater than 1 months; 6. Karnofsky score = 60, ECOG= 2; 7. Important organ function as defined by the following: cardiac ejection fraction = 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula =40ml/min; ALT/AST= 3×the institution normal upper limit; total bilirubin =2.0mg/dl; coagulation function: PT/ APPT92%; Blood: hemoglobin>80g/L, ANC = 1, PLT = 50×10^9/L; 8. There is measurable target lesion; 9. Voluntary informed consent is given.

Exclusion criteria

Exclusion criteria: 1. Immunosuppressive drugs or hormones were used a week before admission; 2. Severe active infection; 3. Human immunodeficiency virus (HIV) positive; 4. Active hepatitis B or C infection; 5. Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study; 6. Patients participating in other clinical trials; 7. The researchers thought the subjects were unfit for inclusion or unable to participate in or complete the study; 8. Patients with congenital immunodeficiency; 9. There is a history of myocardial infarction and serious arrhythmia within six months.

Design outcomes

Primary

MeasureTime frame
Overall remission rate, ORR;Progression free survival time, PFS;Median survival time, MS;Overall survival time, OS;

Countries

China

Contacts

Public ContactYunwei Wei

First Affiliated Hospital of Harbin Medical University

hydwyw11@hotmail.com+86 13936660882

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026