Status:
UNKNOWN
Clinical Trial of Autologous Tcm Immunotherapy in ICC
Lead Sponsor:
Newish Technology (Beijing) Co., Ltd.
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 cholangioc...
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 palliati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03820310
Start Date
May 1 2018
End Date
December 1 2025
Last Update
May 24 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China