Clinical trial · Observational
A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
NCT03695952CI-TRIAL-00085202active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab or pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hepatocellular carcinoma
- description
- Hepatocellular carcinoma patients treated with nivolumab
- interventionNames
- Drug: Nivolumab or pembrolizumab
- label
- Biliary Tract Cancer
- description
- Biliary tract cancer patients treated with pembrolizumab
- interventionNames
- Drug: Nivolumab or pembrolizumab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 6 months
- description
- Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma * Planned immune checkpoint inhibitors including nivolumab or pembrolizumab * Written informed consent Exclusion Criteria: * Not available for the treatment with immune checkpoint inhibitors
References
Publications (1)
- DERIVEDChuah 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. PMID 35430299