NCT03820310

Clinical Trial of Autologous Tcm Immunotherapy in ICC

Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Newish Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The prime purpose of this trial is to evaluate the Progression Free survival 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. Patients will be randomized 1:1 either to the experimental group to receive autologous Tcm cellular immunotherapy and chemotherapy or to the control group (traditional therapy).

Detailed description

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2019-01-29
• Last updated: 2023-05-24

Locations

1 site across 1 country: China