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

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).

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Biological: autologous Tcm cellular immunotherapy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haifeng Xu, M.D; Phone Number: +86-13161554560; Email: 793433066@qq.com
• Study Contact Backup: Name: Xiao-E Yan, Ph.D; Phone Number: +86-18210236948; Email: yanxiaoe@newishes.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Haifeng Xu, M.D; Phone Number: 13161554560; Email: 793433066@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The long-term survival of ICC subjects	The long-term survival of ICC subjects treated with Tcm cellular immunotherapy and traditional therapy.	24 months

Collaborators and Investigators

• Sponsor: Newish Technology (Beijing) Co., Ltd.
• Collaborators: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Shunda Du, M.D, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: intrahepatic cholangiocarcinoma; malignancy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: CH-IT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No