NCT03820310

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

7.1 years

First QC Date

January 25, 2019

Last Update Submit

May 23, 2023

Conditions

Cholangiocarcinoma

Keywords

malignancyintrahepatic cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival

    The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.

    24 months

  • Two-year survival

    Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.

    24 months

Secondary Outcomes (1)

  • The long-term survival of ICC subjects

    24 months

Study Arms (2)

Experimental group

EXPERIMENTAL

traditional therapy plus autologous Tcm cellular immunotherapy.

Biological: autologous Tcm cellular immunotherapy

control group

NO INTERVENTION

traditional therapy alone, such as radiotherapy or chemotherapy.

Interventions

autologous Tcm cellular immunotherapyBIOLOGICAL

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.

Experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and able to provide written informed consent for the trial
  • Subjects treated with radical resection completely, and pathologically confirmed intrahepatic cholangiocarcinoma
  • Subjects with image examination confirmed complete response (CR) postoperatively
  • Age between 18 and 70 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Normal hematopoietic function:
  • White Blood Cell (WBC) ≥ 4×10\^9 /L Neutrophil ≥ 2×10\^9 /L Hemoglobin ≥ 90 g /L Platelets ≥ 100×10\^9 /L
  • Lymphocyte ≥ 0.7×10\^9 /L
  • Adequate Liver and kidney function Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 the upper limit of normal (ULN) for the institution Total bilirubin (TBIL) ≤ 1.5 the upper limit of ULN Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN Creatinine clearance ≥ 70 ml/min
  • Subjects without significant cardiovascular and lung disease

You may not qualify if:

  • Subjects with recurrent intrahepatic cholangiocarcinoma
  • Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
  • Subjects with severe abnormality of coagulation;
  • History or any evidence of hemorrhage.
  • Subjects with bone marrow transplant or severe leukopenia
  • Subjects with severe heart, liver or kidney diseases.
  • Subjects with severe infection or high fever.
  • Subjects with severe autoimmune diseases.
  • Subjects infected with HIV
  • Subjects combined with other malignancies
  • Subjects with T-cell lymphma or tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

CholangiocarcinomaNeoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Shunda Du, M.D

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifeng Xu, M.D

CONTACT

+86-13161554560793433066@qq.com

Xiao-E Yan, Ph.D

CONTACT

+86-18210236948yanxiaoe@newishes.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

May 1, 2018

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)