Hepatocellular CarcinomaNCT03695952
A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
An observational study of Hepatocellular Carcinoma and Biliary Tract Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Biliary Tract Cancer
- What is being tested?
- Nivolumab or pembrolizumab
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2018to 30 Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatobiliary cancer patients treated with nivolumab or pembrolizumab
Who may be able to join
- Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
- Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
- Written informed consent
Who cannot join
- Not available for the treatment with immune checkpoint inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.
Read the detailed description
Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Being tested
- Nivolumab or pembrolizumab
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab or pembrolizumabDrug
Also called Immune checkpoint inhibitors
Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma | Hepatocellular carcinoma patients treated with nivolumab Receives: Drug: Nivolumab or pembrolizumab | |
| Biliary Tract Cancer | Biliary tract cancer patients treated with pembrolizumab Receives: Drug: Nivolumab or pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
Measured: 6 months
Secondary outcomes (1)
Adverse events
Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Jul 2018
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changhoon Yoo, Asan Medical Center
- Investigators
- Changhoon Yoo, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695952
- Sponsor's protocol ID
- ICI_Biomarker
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2018
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuah S, Lee J, Song Y, Kim HD, Wasser M, Kaya NA, Bang K, Lee YJ, Jeon SH, Suthen S, A'Azman S, Gien G, Lim CJ, Chua C, Hazirah SN, Lee HK, Lim JQ, Lim TKH, Yeong J, Chen J, Shin EC, Albani S, Zhai W, Yoo C, Liu H, Choo SP, Tai D, Chew V. Uncoupling immune trajectories of response and adverse events from anti-PD-1 immunotherapy in hepatocellular carcinoma. J Hepatol. 2022 Sep;77(3):683-694. doi: 10.1016/j.jhep.2022.03.039. Epub 2022 Apr 15.
PubMed 35430299
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT03695952
- Acronym / sponsor ID
- ICI_Biomarker
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 4 Oct 2018 (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.
Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.
Detailed description
Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma | – | Drug: Nivolumab or pembrolizumabHepatocellular carcinoma patients treated with nivolumab |
| Biliary Tract Cancer | – | Drug: Nivolumab or pembrolizumabBiliary tract cancer patients treated with pembrolizumab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatobiliary cancer patients treated with nivolumab or pembrolizumab
Key inclusion criteria (3 listed)
- Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
- Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
- Written informed consent
Key exclusion criteria (1 listed)
- Not available for the treatment with immune checkpoint inhibitors
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 |
|---|---|---|
| Nivolumab or pembrolizumabAlso: Immune checkpoint inhibitorsNivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks | Drug | Biliary Tract Cancer, Hepatocellular carcinoma |
Primary outcome
Objective response rate
Time frame: 6 months
Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
1 secondary outcome
Adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 35430299Chuah S, Lee J, Song Y, Kim HD, Wasser M, Kaya NA, Bang K, Lee YJ, Jeon SH, Suthen S, A'Azman S, Gien G, Lim CJ, Chua C, Hazirah SN, Lee HK, Lim JQ, Lim TKH, Yeong J, Chen J, Shin EC, Albani S, Zhai W, Yoo C, Liu H, Choo SP, Tai D, Chew V. Uncoupling immune trajectories of response and adverse events from anti-PD-1 immunotherapy in hepatocellular carcinoma. J Hepatol. 2022 Sep;77(3):683-694. doi: 10.1016/j.jhep.2022.03.039. Epub 2022 Apr 15.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular 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
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.
Changhoon Yoo, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Biliary Tract Cancer, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. 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 South Korea. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695952, which also lists 1 linked publication.
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 28 Jan 2025.