Immunotherapy combo shows promise in bile duct cancer trial
NCT ID NCT03875235
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced biliary tract cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Above or across? trial tests which stent placement keeps bile flowing longer
- Burning away bile duct blockages: a new weapon against cholangiocarcinoma?
- Can a Three-Drug chemo cocktail before surgery stop biliary tract cancer from coming back?
- Can a targeted pill shrink hard-to-treat bile duct cancers?
- Can a targeted drug combo outsmart bile duct cancer?
- Cutting scans, keeping safety: a new streamlined approach to liver cancer treatment