Who is sponsoring NCT04523402?

NCT04523402 is sponsored by Eastern Hepatobiliary Surgery Hospital.

What drugs are being tested in NCT04523402?

Interventions in NCT04523402: Neoadjuvant chemotherapy.

What condition does NCT04523402 study?

NCT04523402 studies Intrahepatic Cholangiocarcinoma Recurrent.

Is NCT04523402 still recruiting?

NCT04523402 is currently status unknown. Last updated 21 August 2020.

Last reviewed 2020-08-21 · How we verify

NCT04523402

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis

Status unknown Phase 2 Last updated 21 August 2020

What this trial tests

Phase 2 trial testing Neoadjuvant chemotherapy in Intrahepatic Cholangiocarcinoma Recurrent in 100 participants. Status unknown.

Timeline

31 December 2020

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Eastern Hepatobiliary Surgery Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	31 December 2020
Primary completion	31 December 2022
Estimated completion	31 December 2023

Drugs / interventions tested

Neoadjuvant chemotherapy — full drug profile →

Conditions studied

Intrahepatic Cholangiocarcinoma Recurrent — all drugs for Intrahepatic Cholangiocarcinoma Recurrent →

Sponsor

Eastern Hepatobiliary Surgery Hospital

Who can join

Adults 18 to 70, any sex, with Intrahepatic Cholangiocarcinoma Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized controlled, open label, phase II clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma (ICC) with high risk of lymph node metastasis as evaluated by our previously established radiomics model, which has low postoperative recurrence-free survival. In this study, we aim to compare the prognosis of ICC patients who undergo liver resection (LR) following preoperative oxaliplatin and gemcitabine (GEMOX) neoadjuvant therapy (experimental arm) versus LR alone (control arm).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Neoadjuvant and Adjuvant Therapy in Intrahepatic Cholangiocarcinoma.
Chen X, Du J, Huang J, Zeng Y, et al · · 2022 · cited 23× · PMID 35836758 · DOI 10.14218/jcth.2021.00250
Intrahepatic cholangiocarcinoma: Evolving role of neoadjuvant and targeted therapy.
Ghio M, Vijay A. · · 2023 · cited 9× · PMID 36823963 · DOI 10.14701/ahbps.22-110
Perioperative and palliative systemic treatments for biliary tract cancer.
Taghizadeh H, Dong Y, Gruenberger T, Prager GW. · · 2024 · cited 4× · PMID 38559612 · DOI 10.1177/17588359241230756
Management of intrahepatic cholangiocarcinoma: a review for clinicians.
Colangelo M, Di Martino M, Polidoro MA, Forti L, et al · · 2025 · cited 3× · PMID 39867595 · DOI 10.1093/gastro/goaf005
Design of studies on neoadjuvant therapy for intrahepatic cholangiocarcinoma.
Cheng Y, Li X. · · 2025 · cited 2× · PMID 39897772 · DOI 10.1016/j.heliyon.2024.e41356
Recent advancements in systemic therapy for biliary tract cancers: a literature review.
Hussain MM, Qammar S, Wang JM, Zhai AQ, et al · · 2025 · PMID 41220768 · DOI 10.21037/jgo-2025-83

Verify or expand the search:

Other trials of Neoadjuvant chemotherapy

Trials testing the same drug.

NCT07081360 — Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer · Phase 3 · recruiting
NCT06978322 — Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Canc · recruiting
NCT06613308 — Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC · not yet recruiting
NCT06386887 — Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer · NA · recruiting
NCT06369480 — Prognostic Factors for Survival in Patients With Cholangiocarcinoma · recruiting

Other Eastern Hepatobiliary Surgery Hospital trials

Trials by the same sponsor.

NCT07363356 — Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer · Phase 2 · not yet recruiting
NCT07351513 — A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma · Phase 2 · not yet recruiting
NCT07351591 — A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers · Phase 2 · not yet recruiting
NCT07285850 — The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD · Phase 2, PHASE3 · recruiting
NCT06902389 — A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04523402 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eastern Hepatobiliary Surgery Hospital
Last refreshed: 21 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04523402.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing