Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2018-05-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
traditional therapy plus autologous Tcm cellular immunotherapy.
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.
control group
traditional therapy alone, such as radiotherapy or chemotherapy.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Newish Technology (Beijing) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shunda Du, M.D
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-IT-004
Identifier Type: -
Identifier Source: org_study_id
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