Clinical Trial of Autologous Tcm Immunotherapy in ICC

  • STATUS
    Recruiting
  • End date
    Dec 16, 2023
  • participants needed
    20
  • sponsor
    Newish Technology (Beijing) Co., Ltd.
Updated on 16 May 2022
pulmonary disease
intrahepatic bile duct carcinoma

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).

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.

Details
Condition Cholangiocarcinoma
Treatment autologous Tcm cellular immunotherapy
Clinical Study IdentifierNCT03820310
SponsorNewish Technology (Beijing) Co., Ltd.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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