New combo therapy aims to fight tough esophageal cancer

NCT ID NCT04550260

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

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

Participants

640 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jun 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 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: * 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

  • Research Site

    Beijing, 100021, China

  • Research Site

    Beijing, 100036, China

  • Research Site

    Bengbu, 233004, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Changzhi, 46000, China

  • Research Site

    Chengdu, 610042, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Fuzhou, 350001, China

  • Research Site

    Fuzhou, 350014, China

  • Research Site

    Guangzhou, 510000, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Hangzhou, China

  • Research Site

    Hefei, 230031, China

  • Research Site

    Huai'an, 223300, China

  • Research Site

    Jieyang, 522000, China

  • Research Site

    Jinan, 250117, China

  • Research Site

    Kunming, 650118, China

  • Research Site

    Liangyugang, 222002, China

  • Research Site

    Nantong, 226361, China

  • Research Site

    Qingdao, 266042, China

  • Research Site

    Quanzhou, 362000, China

  • Research Site

    Shenzhen, 518116, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xuzhou, 221000, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhenjiang, 212002, China

  • Research Site

    Besançon, 25030, France

  • Research Site

    Lille, 59000, France

  • Research Site

    Lyon, 69008, France

  • Research Site

    Montpellier, 34070, France

  • Research Site

    Reims, 51100, France

  • Research Site

    Rouen, 76031, France

  • Research Site

    Strasbourg, 67033, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Hidaka-shi, 350-1298, Japan

  • Research Site

    Hirakata-shi, 573-1191, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kumamoto, 860-8556, Japan

  • Research Site

    Maebashi, 371-8511, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Osaka, 545-8586, Japan

  • Research Site

    Ota-shi, 373-8550, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Shinagawa-ku, 142-8666, Japan

  • Research Site

    Yokohama, 232-0024, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Chihuahua City, 31210, Mexico

  • Research Site

    Cuernavaca, 62290, Mexico

  • Research Site

    Mérida, 97134, Mexico

  • Research Site

    Monterrey, 66220, Mexico

  • Research Site

    Veracruz, 91851, Mexico

  • Research Site

    Katowice, 40-074, Poland

  • Research Site

    Krakow, 31-115, Poland

  • Research Site

    Lodz, 90-513, Poland

  • Research Site

    Siedlce, 08-110, Poland

  • Research Site

    Warsaw, 02-034, Poland

  • Research Site

    Chelyabinsk, 454087, Russia

  • Research Site

    Krasnodar, 350040, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Obninsk, 249031, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Tyumen, 6250041, Russia

  • Research Site

    Ufa, 450054, Russia

  • Research Site

    Yekaterinburg, 620905, Russia

  • Research Site

    Daegu, 41404, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 138-736, South Korea

  • Research Site

    Suwon, 16247, South Korea

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Changhua, 50006, Taiwan

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 40443, Taiwan

  • Research Site

    Taichung, 407, Taiwan

  • Research Site

    Tainan, 710, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

  • Research Site

    Bangkok, 10300, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Chanthaburi, 22000, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Diyarbakır, 21280, Turkey (Türkiye)

  • Research Site

    Erzurum, 25240, Turkey (Türkiye)

  • Research Site

    Goztepe Istanbul, Turkey (Türkiye)

  • Research Site

    Izmir, 35575, Turkey (Türkiye)

  • Research Site

    Van, 65080, Turkey (Türkiye)

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Ho Chi Minh City, Vietnam

  • Research Site

    Atlanta, Georgia, 30308, United States

  • Research Site

    Louisville, Kentucky, 40217, United States

  • Research Site

    Dallas, Texas, 75390, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Morgantown, West Virginia, 26506, United States

  • Research Site

    Brussels, 1090, Belgium

  • Research Site

    Charleroi, 6060, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Namur, 5000, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Fortaleza, 60430-230, Brazil

  • Research Site

    Porto Alegre, 90050-170, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    Vitória, 29043-260, Brazil

  • Research Site

    Barrie, Ontario, L4M 6M2, Canada

  • Research Site

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Research Site

    Anyang, 455000, China

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