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Immunotherapy duo shows promise in Tough-to-Treat esophageal cancer

NCT ID NCT04540211

Disease control Sponsor: Hoffmann-La Roche 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 2 times

Summary

This phase 3 trial tested whether adding two immunotherapy drugs, atezolizumab and tiragolumab, to standard chemotherapy could help people with advanced esophageal cancer live longer. About 461 participants received either the immunotherapy combo plus chemo or a placebo plus chemo. The study measured how long it took for the cancer to worsen and overall survival. The goal is to find a more effective first-line treatment for this hard-to-treat cancer.

What this could mean

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

Active substance
Atezolizumab (Tecentriq) and tiragolumab, combined with chemotherapy drugs paclitaxel and cisplatin
What this could lead to
If successful, this combination could become a new first-line treatment option for advanced esophageal cancer, potentially improving how long patients live without their cancer growing.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. Adding immunotherapy to chemo can cause more side effects, and not all patients may benefit. The benefit may be modest or limited to certain subgroups.

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

461 people

The number who actually took part.

Started

Oct 2020

Finished

Aug 2025

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.

Key Inclusion Criteria: * Histologically confirmed EC * Unresectable locally advanced, unresectable recurrent, or metastatic disease * Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and end-organ function * Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose * Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose Key Exclusion Criteria: * Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment * Evidence of complete esophageal obstruction not amenable to treatment * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Active or history of autoimmune disease or immune deficiency or leptomeningeal disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome * Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety * Positive test result for human immunodeficiency virus (HIV) * Active hepatitis B or hepatitis C * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with any investigational therapy prior to initiation of study treatment * Poor peripheral venous access * Prior allogeneic stem cell or solid organ transplantation * Concurrent participation in another therapeutic clinical trial

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma

As listed by the trial registrant

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

Esophageal cancer

Contacts and locations

Locations

  • Affiliated Hopsital of Jining Medical University

    Jining, China

  • Affiliated Hospital of Chengde Medical University

    Chengde, 067020, China

  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )

    Wuxi, 214122, China

  • Anhui Province Cancer Hospital

    Hefei, 12345, China

  • Anhui Provincial Hospital

    Anhui, 230001, China

  • Anyang Tumor Hosptial

    Anyang, 455000, China

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beijing Luhe Hospital Capital Medical University

    Beijing, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041, China

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohisung, Taiwan

  • Chongqing Sanxia Central Hospital

    Chongqing, 404000, China

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Fujian Provincial Hospital

    Fuzhou, China

  • Gansu Province People Hospital

    Lanzhou, 730000, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Huai'an First People's Hospital

    Huai'an, China

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Jiangsu Cancer Hospital

    Nanjing, 211100, China

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, 210029, China

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042, China

  • Linyishi Cancer Hospital

    Linyi, 276034, China

  • Nan Tong Tumor Hospital

    Nantong, 226361, China

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 00704, Taiwan

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • Northern Jangsu People's Hospital

    Yangzhou, 225001, China

  • Prince of Wales Hosp

    Shatin, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Chest Hospital

    Shanghai, 200000, China

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041, China

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Southern Medical University Nanfang Hospital

    Guangdong Province Guangzhou City, 510515, China

  • Suining Central Hospital

    Suining, 629000, China

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The First Affiliated Hospital to Henan University of Science and Technology

    Luoyang, 471003, China

  • The First People's Hospital of Foshan

    Foshan, 510000, China

  • The First People's Hospital of Lian Yun Gang

    Lianyungang, 222002, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601, China

  • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

    Xi'an, 710038, China

  • The Second People's Hospital of Huai'an

    Huai'an, China

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Weifang People's Hospital

    Weifang, China

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Xiangyang Central Hospital

    Xiangyang, China

  • Xuzhou Central Hospital

    Xuzhou, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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