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Immunotherapy combo shows promise in bile duct cancer trial

NCT ID NCT03875235

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding the immunotherapy drug durvalumab to standard chemotherapy (gemcitabine plus cisplatin) helps people with advanced biliary tract cancer live longer. About 810 participants received either durvalumab or a placebo alongside chemo. The study measures overall survival and how long the cancer stays under control.

What this could mean

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

Active substance
durvalumab (an immunotherapy drug) combined with gemcitabine and cisplatin (chemotherapy)
What this could lead to
If it works, this could offer a new first-line treatment option that helps people with advanced biliary tract cancer live longer.
What could go wrong
This is a late-stage trial, but results are not yet final. The added benefit of durvalumab may be modest, and immunotherapy can cause immune-related side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

810 people

The number who actually took part.

Started

Apr 2019

Expected to finish

May 2027

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 to 130 years

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 1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. 2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible. 3. Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible. 4. WHO/ECOG PS of 0 or 1 Exclusion 1. History of another primary malignancy 2. Brain metastases or spinal cord compression 3. Uncontrolled intercurrent illness 4. Major surgical procedure within 28 days prior to the first dose of IP. 5. Prior locoregional therapy such as radioembolization

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site

    Los Angeles, California, 90027, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

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

  • Research Site

    Fort Myers, Florida, 33905, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Westwood, Kansas, 66205, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    Burlington, Massachusetts, 01805, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    Portland, Oregon, 97213, United States

  • Research Site

    Philadelphia, Pennsylvania, 19111, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Buenos Aires, C1118AAT, Argentina

  • Research Site

    CABA, C1012AAR, Argentina

  • Research Site

    CABA, C1019ABS, Argentina

  • Research Site

    Ciudad de Buenos Aires, 1280, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1426ANZ, Argentina

  • Research Site

    Rosario, 2000, Argentina

  • Research Site

    San Salvador de Jujuy, 4600, Argentina

  • Research Site

    Burgas, 8000, Bulgaria

  • Research Site

    Sofia, 1330, Bulgaria

  • Research Site

    Sofia, 1407, Bulgaria

  • Research Site

    Sofia, 1606, Bulgaria

  • Research Site

    Varna, 9010, Bulgaria

  • Research Site

    Santiago, 7630370, Chile

  • Research Site

    Temuco, 4810218, Chile

  • Research Site

    Baoding, 071000, China

  • Research Site

    Beijing, 100021, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Bengbu, 233004, China

  • Research Site

    Chongqing, 400038, China

  • Research Site

    Foshan, 528000, China

  • Research Site

    Guangzhou, 510062, China

  • Research Site

    Hangzhou, 310003, China

  • Research Site

    Hangzhou, 310009, China

  • Research Site

    Harbin, 150081, China

  • Research Site

    Hefei, 230001, China

  • Research Site

    Hefei, 230601, China

  • Research Site

    Jinan, 250014, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210002, China

  • Research Site

    Shandong, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 100003, China

  • Research Site

    Suzhou, 215004, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhuhai, 519000, China

  • Research Site

    Clichy, 92210, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Montpellier, 34295, France

  • Research Site

    Nice, 6189, France

  • Research Site

    Paris, 75571, France

  • Research Site

    Pessac, 33604, France

  • Research Site

    Poitiers, 86021, France

  • Research Site

    Hong Kong, 00000, Hong Kong

  • Research Site

    Hong Kong, 150001, Hong Kong

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Kowloon, Hong Kong

  • Research Site

    Gurgaon, 122001, India

  • Research Site

    Kolkata, 700160, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    New Delhi, 110085, India

  • Research Site

    Faenza, 48018, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    Mitaka-shi, 181-8611, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Poznan, 60-780, Poland

  • Research Site

    Warsaw, 02-106, Poland

  • Research Site

    Wroclaw, 50-556, Poland

  • Research Site

    Barnaul, 656049, Russia

  • Research Site

    Kostroma, 156005, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 121467, Russia

  • Research Site

    Moscow, 125284, Russia

  • Research Site

    Omsk, 644033, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 152-703, South Korea

  • Research Site

    Chiayi City, 613, Taiwan

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10050, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Si Sa Ket, 33000, Thailand

  • Research Site

    Ankara, 06100, Turkey (Türkiye)

  • Research Site

    Istanbul, 34030, Turkey (Türkiye)

  • Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    Mersin, 33110, Turkey (Türkiye)

  • Research Site

    Bristol, BS2 8ED, United Kingdom

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    London, NW3 2QG, United Kingdom

  • Research Site

    London, W12 0NN, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Oxford, OX3 7LE, United Kingdom

  • Research Site

    Romford, RM7 0AG, United Kingdom

  • Research Site

    Sheffield, S10 2SJ, United Kingdom

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Other studies related to the condition(s) this trial covers.