Clinical trial NCT03820310: Clinical Trial of Autologous Tcm Immunotherapy in ICC
Official title: Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: malignancy
intrahepatic cholangiocarcinoma
Lead sponsor: Newish Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2019-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 months
measure: Two-year survival
timeFrame: 24 months
Secondary outcomes:
measure: The long-term survival of ICC subjects
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shunda Du, M.D
role: PRINCIPAL_INVESTIGATOR
References: