CholangiocarcinomaPhase 2NCT03820310
Clinical Trial of Autologous Tcm Immunotherapy in ICC
A Phase 2 study testing autologous Tcm cellular immunotherapy in people with Cholangiocarcinoma, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- autologous Tcm cellular immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Haifeng Xu, M.D, 13161554560, 793433066@qq.com
About this study
Official title: Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
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).
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- autologous Tcm cellular immunotherapy
- Keywords
- malignancy, intrahepatic cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous Tcm cellular immunotherapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | traditional therapy plus autologous Tcm cellular immunotherapy. Receives: Biological: autologous Tcm cellular immunotherapy |
| control group | No intervention | traditional therapy alone, such as radiotherapy or chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
Measured: 24 months
Two-year survival
Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
Measured: 24 months
Secondary outcomes (1)
The long-term survival of ICC subjects
The long-term survival of ICC subjects treated with Tcm cellular immunotherapy and traditional therapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 May 2018
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Shunda Du, M.D, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820310
- Sponsor's protocol ID
- CH-IT-004
- Status last verified
- May 2023
- First submitted
- 25 Jan 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
- ClinicalTrials.gov ID
- NCT03820310
- Acronym / sponsor ID
- CH-IT-004
- Conditions
- Cholangiocarcinoma
- Keywords
- malignancy, intrahepatic cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: autologous Tcm cellular immunotherapytraditional therapy plus autologous Tcm cellular immunotherapy. |
| control group | No intervention | –traditional therapy alone, such as radiotherapy or chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous Tcm cellular immunotherapyautologous 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. | Biological | Experimental group |
Primary outcome
Progression Free Survival
Time frame: 24 months
The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
Two-year survival
Time frame: 24 months
Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
1 secondary outcome
The long-term survival of ICC subjects
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunda Du, M.D principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous Tcm cellular immunotherapy in people with Cholangiocarcinoma, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haifeng Xu, M.D (+86-13161554560, 793433066@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.