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Clinical Trial of Autologous Tcm Immunotherapy in ICC

NCT03820310 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-24

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Newish Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shunda Du, M.D · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820310 on ClinicalTrials.gov