Using patients' own immune cells to treat intrahepatic cholangiocarcinoma after surgery

Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection

This study is testing whether using patients' own immune cells along with standard treatments can help people with intrahepatic cholangiocarcinoma live longer and stay cancer-free after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Newish Technology (Beijing) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT03820310 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of combining autologous Tcm cellular immunotherapy with traditional therapies in patients with intrahepatic cholangiocarcinoma (ICC) following radical resection. Participants will be randomly assigned to receive either the experimental treatment or standard therapy. The primary focus is on progression-free survival and two-year survival rates, while secondary objectives include assessing long-term survival and safety. The study aims to enhance the anti-tumor immune response using the patient's own immune cells, which are cultured and reintroduced into the body.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed ICC who have undergone radical resection and have adequate organ function.

Not a fit: Patients with recurrent intrahepatic cholangiocarcinoma or significant cardiovascular and lung diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with intrahepatic cholangiocarcinoma.

How similar studies have performed: Other studies have shown promise in using cellular immunotherapy for cancer treatment, suggesting potential success for this novel approach.

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

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Shunda Du, M.D — Peking Union Medical College Hospital
• Study coordinator: Haifeng Xu, M.D

Conditions Cholangiocarcinoma; malignancy; intrahepatic cholangiocarcinoma