Clinical Trial of Autologous Tcm Immunotherapy in ICC

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cholangiocarcinoma

Clinical Trial Details

NCT number	NCT03820310
Study type	Interventional
Source	Newish Technology (Beijing) Co., Ltd.
Contact	Haifeng Xu, M.D
Phone	+86-13161554560
Email	793433066@qq.com
Status	Recruiting
Phase	Phase 2
Start date	May 1, 2018
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT05678218` - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05179486` - Molecular Epidemiology of Biliary Tree Cancers
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Terminated	`NCT04304781` - Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer	Phase 1
Completed	`NCT03150615` - Enteral Nutrition After Pancreaticoduodenectomy	N/A
Completed	`NCT01912053` - Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma	Phase 2
Recruiting	`NCT01439698` - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	N/A
Terminated	`NCT01434459` - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin	Phase 1
Completed	`NCT01206049` - Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations	Phase 2
Recruiting	`NCT00973713` - Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol	Phase 2
Terminated	`NCT00975039` - Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma	Phase 2
Completed	`NCT00779454` - Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma	Phase 2
Terminated	`NCT04066491` - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC	Phase 2/Phase 3
Recruiting	`NCT04340986` - Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
Active, not recruiting	`NCT04526106` - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT03603834` - Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma	Phase 2
Recruiting	`NCT05007106` - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)	Phase 2