Clinical Trial of Autologous Tcm Immunotherapy in ICC
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|ClinicalTrials.gov Identifier: NCT03820310|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Biological: autologous Tcm cellular immunotherapy||Phase 2|
Intrahepatic cholangiocarcinoma (ICC) accounts for 2%~3% of gastrointestinal tumors, and the incidence has been on the rise globally. The pathogenesis of ICC remains unclearly. Compared with palliative resection, the postoperative survival rate of patients undergoing radical resection is significantly improved. However, most patients after radical resection will recurrence or metastasis, and the five-year overall survival rate is about 10-40%.
Autologous cellular immunotherapy is to collect patient's own immune cells and infuse into the patient's body after culture in vitro that can activate the anti-tumor immune response and then achieve the purpose of cancer treatment. Central memory T cells (Tcm) is the most effective anti-tumor immune cell with long-term in vivo survival and self-renewal capacity. Combination of autologous cellular immunotherapy with traditional therapies, such as radiotherapy or chemotherapy, can effectively prolong the survival period of patients, and improve the quality of life for patients.
This study will recruit subjects with pathologically confirmed intrahepatic cholangiocarcinoma after radical resection. Patients must have adequate hematologic and end organ function, performance status and no contraindications to receive autologous cellular immunotherapy.
The observation period of patients is 24 months. The prime purpose of this trial is to evaluate the Progression Free Survival (PFS) and two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in intrahepatic cholangiocarcinoma (ICC) patients after radical resection. A secondary objective of the trial is to assess the long-term survival and safety of Tcm cellular immunotherapy and traditional therapy in ICC patients after radical resection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
Experimental: Experimental group
traditional therapy plus autologous Tcm cellular immunotherapy.
Biological: autologous Tcm cellular immunotherapy
autologous cellular immunotherapy plus traditional therapy. • cells will be infused in 3-5×109 cells/100 ml 1 month after radical resection, then cells will be infused as the same dose followed by a 1 month rest period, Each subject in experimental group will receive a total of 5 cell infusions.
No Intervention: control group
traditional therapy alone, such as radiotherapy or chemotherapy.
- Progression Free Survival [ Time Frame: 24 months ]The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
- Two-year survival [ Time Frame: 24 months ]Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
- The long-term survival of ICC subjects [ Time Frame: 24 months ]The long-term survival of ICC subjects treated with Tcm cellular immunotherapy and traditional therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820310
|Contact: Shunda Xu, M.Dfirstname.lastname@example.org|
|Contact: Xiao-E Yan, Ph.Demail@example.com|
|Principal Investigator:||Shunda Du, M.D||Peking Union Medical College Hospital|