Who is sponsoring NCT05170438?

NCT05170438 is sponsored by National Health Research Institutes, Taiwan.

What drugs are being tested in NCT05170438?

Interventions in NCT05170438: Lenvatinib Pill,Paclitaxel.

What condition does NCT05170438 study?

NCT05170438 studies Advanced Biliary Tract Cancer.

Is NCT05170438 still recruiting?

NCT05170438 is currently active, enrolled. Last updated 15 January 2026.

Last reviewed 2026-01-15 · How we verify

NCT05170438: LenPac

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

Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment

Active, enrolled Phase 2 Last updated 15 January 2026

What this trial tests

Phase 2 trial testing Lenvatinib Pill,Paclitaxel in Advanced Biliary Tract Cancer in 51 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 July 2022

Primary endpoint
1 June 2028

1 June 2028

Quick facts

Lead sponsor	National Health Research Institutes, Taiwan
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	1 July 2022
Primary completion	1 June 2028
Estimated completion	1 June 2028
Sites	8 locations across Taiwan

Drugs / interventions tested

Lenvatinib Pill,Paclitaxel — full drug profile →

Conditions studied

Advanced Biliary Tract Cancer — all drugs for Advanced Biliary Tract Cancer →

Sponsor

National Health Research Institutes, Taiwan

Who can join

20 and older, any sex, with Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall response rate
Time frame: 2 year
Overall response rate (ORR) by RECIST 1.1

Sponsor's own description

To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of life Safety profile Predictive biomarker of cholangiocarcinoma

Publications & conference data

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

Gallbladder cancer: current and future treatment options.
Zhou Y, Yuan K, Yang Y, Ji Z, et al · · 2023 · cited 40× · PMID 37251319 · DOI 10.3389/fphar.2023.1183619
Recent Advances in Systemic Therapy for Advanced Intrahepatic Cholangiocarcinoma.
Yoo C, Hyung J, Chan SL. · · 2024 · cited 19× · PMID 38638168 · DOI 10.1159/000531458
Current Status of Targeted Therapy for Biliary Tract Cancer in the Era of Precision Medicine.
Mie T, Sasaki T, Okamoto T, Furukawa T, et al · · 2024 · cited 5× · PMID 38473240 · DOI 10.3390/cancers16050879
New Relevant Evidence in Cholangiocarcinoma Biology and Characterization.
Porro N, Spínola-Lasso E, Pastore M, Caligiuri A, et al · · 2024 · cited 1× · PMID 39766138 · DOI 10.3390/cancers16244239

Verify or expand the search:

Other recruiting trials for Advanced Biliary Tract Cancer

Currently open trials in the same condition.

NCT06988592 — GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1） · recruiting
NCT04969887 — Combination Immunotherapy in Rare Cancers Under InvesTigation · Phase 2 · active not recruiting
NCT04727996 — Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer · Phase 2 · active not recruiting
NCT04005339 — NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer · Phase 2 · active not recruiting

Other National Health Research Institutes, Taiwan trials

Trials by the same sponsor.

NCT07579832 — Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 · NA · not yet recruiting
NCT06981637 — Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Contr · Phase 2 · recruiting
NCT07177365 — Internet-Based Cognitive Behavioral Therapy With Treatment as Usual for Generalized Anxiety Disorder and Major Depressiv · NA · not yet recruiting
NCT07138261 — Taiwanese Anaplastic Thyroid Cancer Registry · not yet recruiting
NCT07151365 — Plant-based Diets and Healthy Aging · 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 NCT05170438 (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 National Health Research Institutes, Taiwan
Last refreshed: 15 January 2026

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/NCT05170438.

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