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Clinical Trial of Autologous Tcm Immunotherapy in ICC

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ClinicalTrials.gov Identifier: NCT03820310
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Newish Technology (Beijing) Co., Ltd.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Biological: autologous Tcm cellular immunotherapy Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be willing and able to provide written informed consent for the trial
  2. Subjects treated with radical resection completely, and pathologically confirmed intrahepatic cholangiocarcinoma
  3. Subjects with image examination confirmed complete response (CR) postoperatively
  4. Age between 18 and 70 years old
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  6. 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

  7. Lymphocyte ≥ 0.7×10^9 /L
  8. 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
  9. Subjects without significant cardiovascular and lung disease

Exclusion Criteria:

  1. Subjects with recurrent intrahepatic cholangiocarcinoma
  2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
  3. Subjects with severe abnormality of coagulation;
  4. History or any evidence of hemorrhage.
  5. Subjects with bone marrow transplant or severe leukopenia
  6. Subjects with severe heart, liver or kidney diseases.
  7. Subjects with severe infection or high fever.
  8. Subjects with severe autoimmune diseases.
  9. Subjects infected with HIV
  10. Subjects combined with other malignancies
  11. Subjects with T-cell lymphma or tumor
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Haifeng Xu, M.D +86-13161554560 793433066@qq.com
Contact: Xiao-E Yan, Ph.D +86-18210236948 yanxiaoe@newishes.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Haifeng Xu, M.D    13161554560    793433066@qq.com   
Sponsors and Collaborators
Newish Technology (Beijing) Co., Ltd.
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Shunda Du, M.D Peking Union Medical College Hospital
More Information
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Responsible Party: Newish Technology (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03820310    
Other Study ID Numbers: CH-IT-004
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newish Technology (Beijing) Co., Ltd.:
malignancy
intrahepatic cholangiocarcinoma
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms