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Can two targeted drugs boost chemo against a rare Bile-Duct cancer?

NCT ID NCT02711553

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding either ramucirumab (a blood-vessel blocker) or merestinib (a cell-signal blocker) to standard chemotherapy (cisplatin + gemcitabine) can help people with advanced or metastatic biliary tract cancer live longer without their disease worsening. About 300 participants will be randomly assigned to one of three groups: chemo plus ramucirumab, chemo plus merestinib, or chemo plus placebo. The study aims to see if either targeted drug improves progression-free survival compared to chemo alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ramucirumab or merestinib added to cisplatin and gemcitabine chemotherapy
What this could lead to
If successful, this could provide a new first-line treatment option for people with advanced biliary tract cancer, potentially slowing tumor growth and extending survival.
What could go wrong
This is an early-phase trial, so the added drugs may not improve outcomes over standard chemo alone. Side effects from combining multiple agents could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

309 people

The number who actually took part.

Started

May 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) . * Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). * Have adequate biliary drainage. * Have adequate organ function. * Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method. * Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose. * Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations. Exclusion Criteria: * Previous systemic therapy for locally advanced or metastatic disease is not allowed. * Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade \>1, or cirrhosis with Child-Pugh Stage B or higher. * Have ongoing or recent (≤6 months) hepatorenal syndrome. * Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization. * Anticipate having a major surgical procedure during the course of the study. * Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. * Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. * Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management. * Have a previous malignancy within 5 years of study entry or a concurrent malignancy. * Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. * Have a known allergy or hypersensitivity reaction to any of the treatment components. * Have a history of uncontrolled hereditary or acquired thrombotic disorder. * Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain. * Have mixed hepatocellular biliary tract cancer histology. * Have a corrected QT interval \>470 milliseconds as calculated by the Fridericia equation.

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Conditions

The condition(s) this trial relates to.

ampulla of vater cancer bile duct adenocarcinoma biliary tract cancer Biliary Tract Neoplasms cancer extrahepatic bile duct carcinoma gallbladder cancer intrahepatic cholangiocarcinoma metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer Biliary tract cancer Metastatic cancer

Contacts and locations

Locations

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus C, 8000, Denmark

  • Akdeniz University Medical Faculty

    Antalya, 07059, Turkey (Türkiye)

  • Alexander Fleming

    CABA, BS, 1426, Argentina

  • Arke Estudios Clinicos S.A. de C.V.

    Mexico City, Mexico City, 06700, Mexico

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045, Russia

  • Asan Medical Center

    Seoul, Korea, 05505, South Korea

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250, Turkey (Türkiye)

  • Blokhin Cancer Research Center

    Moscow, 115478, Russia

  • CHRU de Montpellier-Hopital St Eloi

    Montpellier, 34295, France

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030, France

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, Gironde, 33075, France

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Centre Antoine-Lacassagne

    Nice, 06189, France

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

    San Juan, J5402DIL, Argentina

  • Centro de Alta Especialidad Reumatologia Inv del Potosi SC

    San Luis Potosí City, 78213, Mexico

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Cliniques universitaires Saint-Luc

    Brussels, Brussels Capital, 1200, Belgium

  • Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Fakultni Nemocnice v Motole

    Prague, 150 06, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Florida Cancer Specialists

    Nashville, Tennessee, 37203, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497, United States

  • Fundacion Ars Medica

    San Salvador de Jujuy, Jujuy Province, Y4600APW, Argentina

  • Fundacion Favaloro

    Ciudad de Buenos Aires, 1093, Argentina

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE, Argentina

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Hacettepe University Faculty of Medicine

    Ankara, 06100, Turkey (Türkiye)

  • Hammersmith Hospital

    Acton, London, W12 0HS, United Kingdom

  • Hospital Clinico de San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valencia

    Barcelona, 46010, Spain

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de Gastroenterologia Udaondo

    Capital Federal, Buenos Aires, C1264AAA, Argentina

  • Hôpital C. HURIEZ

    Lille, 59037, France

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098, Turkey (Türkiye)

  • KH der Barmherzigen Brüder Wien

    Vienna, 1020, Austria

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karolinska Universitetssjukhuset i Solna

    Stockholm, 17176, Sweden

  • Landesklinikum Wr. Neustadt

    Wiener Neustadt, Lower Austria, 2700, Austria

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53, Czechia

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625, Germany

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704, Taiwan

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 198255, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Skåne universitetssjukhus

    Malmö, 20502, Sweden

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre

    Bebbington, Merseyside, CH63 4JY, United Kingdom

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University College Hospital - London

    London, Greater London, NW1 2BU, United Kingdom

  • University of Florida School of Medicine

    Gainesville, Florida, 32608, United States

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Salzburg

    Salzburg, 5020, Austria

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Washington University Medical School

    City of Saint Peters, Missouri, 63376, United States

  • Washington University Medical School

    Creve Coeur, Missouri, 63141, United States

  • Washington University Medical School

    St Louis, Missouri, 63110, United States

  • Washington University Medical School

    St Louis, Missouri, 63129, United States

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