New combo therapy aims to fight tough esophageal cancer
NCT ID NCT04550260
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding the immunotherapy drug durvalumab to standard chemoradiation helps people with advanced esophageal cancer that cannot be removed by surgery. About 640 participants will receive either durvalumab or a placebo alongside their cancer treatment. The study measures how long the cancer stays under control and overall survival.
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)
- What this could lead to
- If successful, this could provide a new treatment option that helps people with advanced esophageal cancer live longer without their cancer growing.
- What could go wrong
- This is a late-stage trial, but immunotherapy doesn't work for everyone and can cause serious side effects. The results may not apply to all patients with this cancer.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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640 people
The number who actually took part.
- Started
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Oct 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Criteria: * 18 years or older at the time of signing the ICF. * Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA). * Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy. * Patients with at least an evaluable lesion per RECIST 1.1. * Mandatory provision of available tumor tissue for PD-L1 expression analysis. * ECOG PS 0 or 1. * Adequate organ and marrow function. * Life expectancy of more than 3 months. Exclusion Criteria: * Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma. * Prior anti-cancer treatment for ESCC. * Patient with a great risk of perforation and massive bleeding. * History of allogeneic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders. * Uncontrolled intercurrent illness. * History of another primary malignancy. * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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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
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Research Site
Beijing, 100021, China
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Research Site
Beijing, 100036, China
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Research Site
Bengbu, 233004, China
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Research Site
Changsha, 410013, China
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Research Site
Changzhi, 46000, China
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Chengdu, 610042, China
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Chongqing, 400030, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510000, China
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Guangzhou, 510060, China
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Hangzhou, China
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Hefei, 230031, China
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Huai'an, 223300, China
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Jieyang, 522000, China
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Jinan, 250117, China
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Kunming, 650118, China
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Liangyugang, 222002, China
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Nantong, 226361, China
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Qingdao, 266042, China
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Quanzhou, 362000, China
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Shenzhen, 518116, China
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Tianjin, 300060, China
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Xi'an, 710061, China
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Xuzhou, 221000, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Zhenjiang, 212002, China
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Besançon, 25030, France
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Lille, 59000, France
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Lyon, 69008, France
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Montpellier, 34070, France
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Reims, 51100, France
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Rouen, 76031, France
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Strasbourg, 67033, France
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Villejuif, 94805, France
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Bunkyō City, 113-8431, Japan
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Research Site
Chūōku, 104-0045, Japan
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Research Site
Hidaka-shi, 350-1298, Japan
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Research Site
Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Maebashi, 371-8511, Japan
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Matsuyama, 791-0280, Japan
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Niigata, 951-8566, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Ota-shi, 373-8550, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Chihuahua City, 31210, Mexico
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Cuernavaca, 62290, Mexico
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Mérida, 97134, Mexico
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Monterrey, 66220, Mexico
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Veracruz, 91851, Mexico
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Katowice, 40-074, Poland
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Krakow, 31-115, Poland
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Lodz, 90-513, Poland
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Siedlce, 08-110, Poland
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Warsaw, 02-034, Poland
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Chelyabinsk, 454087, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Obninsk, 249031, Russia
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Saint Petersburg, 197758, Russia
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Tyumen, 6250041, Russia
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Ufa, 450054, Russia
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Yekaterinburg, 620905, Russia
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Daegu, 41404, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 138-736, South Korea
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Suwon, 16247, South Korea
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Zaragoza, 50009, Spain
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Changhua, 50006, Taiwan
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Research Site
Kaohsiung City, 80756, Taiwan
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Research Site
Kaohsiung City, 82445, Taiwan
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Research Site
Kaohsiung City, 83301, Taiwan
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Taichung, 40443, Taiwan
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Taichung, 407, Taiwan
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Research Site
Tainan, 710, Taiwan
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Research Site
Taipei, 10002, Taiwan
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Research Site
Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Research Site
Bangkok, 10300, Thailand
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Research Site
Bangkok, 10330, Thailand
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Research Site
Bangkok, 10400, Thailand
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Research Site
Chanthaburi, 22000, Thailand
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Chiang Mai, 50200, Thailand
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Research Site
Hat Yai, 90110, Thailand
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Research Site
Khon Kaen, 40002, Thailand
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Research Site
Ankara, 06800, Turkey (Türkiye)
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Research Site
Diyarbakır, 21280, Turkey (Türkiye)
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Research Site
Erzurum, 25240, Turkey (Türkiye)
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Research Site
Goztepe Istanbul, Turkey (Türkiye)
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Research Site
Izmir, 35575, Turkey (Türkiye)
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Van, 65080, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, Vietnam
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Atlanta, Georgia, 30308, United States
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Louisville, Kentucky, 40217, United States
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Dallas, Texas, 75390, United States
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Fairfax, Virginia, 22031, United States
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Morgantown, West Virginia, 26506, United States
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Brussels, 1090, Belgium
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Charleroi, 6060, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Barretos, 14784-400, Brazil
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Fortaleza, 60430-230, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Vitória, 29043-260, Brazil
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Barrie, Ontario, L4M 6M2, Canada
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Research Site
Greater Sudbury, Ontario, P3E 5J1, Canada
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Research Site
Anyang, 455000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Triple-Drug combo shrink esophageal tumors before surgery?
- Can a Triple-Drug combo wipe out esophageal tumors before surgery?
- Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer
- Can a targeted pill outperform chemotherapy in tough esophageal cancer?
- Can a standardized MRI accurately stage esophageal cancer?
- Can a new infusion drug shrink Hard-to-Treat tumors?