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Phase Ib clinical study on the safety of DC-CIK cell immunotherapy in patients with pancreatic cancer after operation

Phase Ib clinical study on the safety of DC-CIK cell immunotherapy in patients with pancreatic cancer after operation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022787
Enrollment
Unknown
Registered
2019-04-25
Start date
2019-12-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Pancreatic Cancer

Interventions

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Understand and sign the informed consent form and comply with the requirements of this study prior to any steps related to this study; 2) Age = 18, gender unlimited; 3) The patients had been operated on for pancreatectomy before they were enrolled in the group. According to the standard for diagnosis and treatment of pancreatic cancer (2018) issued by China Health Commission, they were diagnosed as pancreatic cancer by pathology and imaging. The routine treatment after operation is arranged according to the specific situation of the patients. If there is a plan for postoperative chemotherapy, all chemotherapy cycles can be completed before entering the group; 4) Expected survival time = 1 year; 5) ECOG = 2 points; 6) No major organ dysfunction, normal renal function and heart function; liver, kidney and blood examination meet the following standards: WBC>3×109/L Neutrophils > 1.5 × 109 / L, Hemoglobin = 85g / L, Platelet = 50 × 109 / L, PT normal or extended time < 3 seconds Urea nitrogen and creatinine = 1.5 times the upper limit of normal value;

Exclusion criteria

Exclusion criteria: 1) Pregnant women, lactating women or those who plan to be pregnant within the next year; 2) Allergic constitution, history of allergy to blood products, known allergy to test products; 3) In half a year, I have systematically or long-term applied immunomodulators such as interferon, thymosin, traditional Chinese medicine (single medicine such as Chaihu, Huaishan, Huangqi, ginseng, etc., compound medicine such as Yupingfeng powder, etc.) and immunosuppressive drugs such as adrenocortical hormone, etc.; systematic or long-term application refers to the continuous and standardized use of immunomodulators for more than three months, and the continuous and standardized use of immunosuppressive drugs More than 1 month; 4) Patients who have received any cell therapy within one month (including NK, CIK, DC-CIK, stem cells, etc.); 5) Patients after organ transplantation; patients with uncontrolled infectious diseases; patients with history of immunodeficiency or autoimmune diseases (such as HIV, rheumatoid arthritis, Berger's disease, multiple sclerosis, type 1 diabetes, etc.); 6) Patients with malignant tumors (excluding skin cancer, local prostate cancer or carcinoma in situ of cervix) within 5 years before enrollment; 7) Those with other organ failure; 8) Those with serious mental illness; 9) Screening evidence of drug addiction in the previous year (including alcoholism); 10) Participated in clinical trials of other drugs within 3 months before screening; 11) At the discretion of the investigator, the patient has any serious acute or chronic physical or mental illness, or laboratory abnormality, which may increase the risk of study participation, study administration, or other serious conditions that may affect the interpretation of the study results.

Design outcomes

Primary

MeasureTime frame
blood routine;Biochemistry;Coagulation function;CRP;Electrocardiogram;Immunity;cytokine;

Secondary

MeasureTime frame
Changes in quality of life (KPS/ECOG score);Changes in Tumor Markers (CEA199);

Countries

China

Contacts

Public ContactQiuhong Zheng

Fujian Cancer Hospital

zqh2858@foxmail.com+86 13805054696

Outcome results

None listed

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