NCT05509478 (LEADER-001) is a Phase 2 clinical trial of Lenvatinib in Biliary Tract Cancer, sponsored by The First Hospital of Jilin University.

Who is sponsoring NCT05509478?

NCT05509478 is sponsored by The First Hospital of Jilin University.

What drugs are being tested in NCT05509478?

Interventions in NCT05509478: Lenvatinib, PD-1 inhibitors.

What condition does NCT05509478 study?

NCT05509478 studies Biliary Tract Cancer.

Is NCT05509478 still recruiting?

NCT05509478 is currently status unknown. Last updated 10 September 2022.

Last reviewed 2022-09-10 · How we verify

NCT05509478: LEADER-001

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

Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract Carcinoma

Status unknown Phase 2 Last updated 10 September 2022

What this trial tests

Phase 2 trial testing Lenvatinib in Biliary Tract Cancer in 46 participants. Status unknown.

Timeline

20 August 2022

Primary endpoint
1 February 2023

1 September 2023

Quick facts

Lead sponsor	The First Hospital of Jilin University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	20 August 2022
Primary completion	1 February 2023
Estimated completion	1 September 2023
Sites	1 location across China

Drugs / interventions tested

Lenvatinib (LENVATINIB) — full drug profile →
PD-1 inhibitors — full drug profile →

Conditions studied

Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

The First Hospital of Jilin University

Who can join

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

Sponsor's own description

This is a multi-center, single-arm,phase Ⅱ study to evaluate the efficacy and safety of Lenvatinib in combination with PD-1 inhibitors as first-line treatment in patients with unresectable advanced Biliary Tract Carcinoma (BTC)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Lenvatinib

Trials testing the same drug.

NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy · Phase 2 · not yet recruiting

Other recruiting trials for Biliary Tract Cancer

Currently open trials in the same condition.

NCT07221253 — A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Bili · Phase 3 · recruiting
NCT06529718 — Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients · Phase 2 · recruiting
NCT07151118 — ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer · recruiting
NCT07142226 — Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC · recruiting
NCT07135544 — A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initial · Phase 2 · recruiting

Other The First Hospital of Jilin University trials

Trials by the same sponsor.

NCT07308340 — Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT · not yet recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
NCT07414160 — Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients · not yet recruiting
NCT07440368 — Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness · not yet recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · 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 NCT05509478 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Hospital of Jilin University
Last refreshed: 10 September 2022

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/NCT05509478.

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