NCT02558959 is a Phase 2 clinical trial of Irinotecan in Biliary Tract Neoplasms, sponsored by Zhejiang University.

Who is sponsoring NCT02558959?

NCT02558959 is sponsored by Zhejiang University.

What drugs are being tested in NCT02558959?

Interventions in NCT02558959: Irinotecan, Capecitabine.

What condition does NCT02558959 study?

NCT02558959 studies Biliary Tract Neoplasms.

Is NCT02558959 still recruiting?

NCT02558959 is currently completed. Last updated 13 February 2018.

Last reviewed 2018-02-13 · How we verify

NCT02558959

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

Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Completed Phase 2 Last updated 13 February 2018

What this trial tests

Phase 2 trial testing Irinotecan in Biliary Tract Neoplasms in 64 participants. Completed in 31 December 2017.

Timeline

1 September 2015

Primary endpoint
30 September 2017

31 December 2017

Quick facts

Lead sponsor	Zhejiang University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	1 September 2015
Primary completion	30 September 2017
Estimated completion	31 December 2017
Sites	1 location across China

Drugs / interventions tested

Irinotecan (irinotecan) — full drug profile →
Capecitabine (capecitabine) — full drug profile →

Conditions studied

Biliary Tract Neoplasms — all drugs for Biliary Tract Neoplasms →

Sponsor

Zhejiang University

Who can join

Adults 18 to 75, any sex, with Biliary Tract Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

Publications & conference data

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

A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin.
Zheng Y, Tu X, Zhao P, Jiang W, et al · · 2018 · cited 61× · PMID 29955136 · DOI 10.1038/s41416-018-0138-2
Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.
Yang W, Sun Y. · · 2021 · cited 17× · PMID 33658799 · DOI 10.2147/ott.s297643

Verify or expand the search:

Other trials of Irinotecan

Trials testing the same drug.

NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha · Phase 3 · not yet recruiting
NCT07474727 — A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer · Phase 2 · not yet recruiting
NCT07381764 — ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected M · Phase 2 · not yet recruiting

Other recruiting trials for Biliary Tract Neoplasms

Currently open trials in the same condition.

NCT06653192 — EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial) · NA · recruiting
NCT04579380 — Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations · Phase 2 · active not recruiting
NCT04308174 — Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer · Phase 2 · active not recruiting
NCT03875235 — Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer · Phase 3 · active not recruiting
NCT03801083 — Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers · Phase 2 · recruiting

Other Zhejiang University trials

Trials by the same sponsor.

NCT07487402 — Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurr · EARLY_PHASE1 · not yet recruiting
NCT07480044 — A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly · NA · not yet recruiting
NCT07467005 — Video Double-Lumen Tube for Secondary Pulmonary Resection · NA · not yet recruiting
NCT07429461 — Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
NCT07240766 — HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation · Phase 2 · 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 NCT02558959 (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 Zhejiang University
Last refreshed: 13 February 2018

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/NCT02558959.

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