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Immunotherapy combo shows promise in esophageal cancer trial

NCT ID NCT03957590

Disease control Sponsor: BeiGene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tested whether adding the immunotherapy drug tislelizumab to standard chemoradiotherapy helps people with localized esophageal squamous cell carcinoma. 370 participants received either tislelizumab or a placebo alongside chemotherapy and radiation. The study measured how long patients lived without their cancer worsening 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
tislelizumab (an immunotherapy drug)
What this could lead to
If successful, this could offer a new treatment option that helps control localized esophageal cancer for longer.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. Immunotherapy can cause immune-related side effects, and not all patients may benefit.

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

370 people

The number who actually took part.

Started

Jun 2019

Finished

Mar 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 to 75 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.

Key Inclusion Criteria: * Histologically confirmed diagnosis of localized ESCC and suitable for concurrent chemoradiotherapy (cCRT) * Measurable and/or non-measurable disease defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Adequate organ function Key Exclusion Criteria: * Indicators of severe malnutrition * Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization * Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy * Received prior radiotherapy or therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1), PD-L2 or other immune-oncology therapies * Active autoimmune diseases or history of autoimmune diseases that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

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

Esophageal squamous cell carcinoma (ESCC)

Contacts and locations

Locations

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Changzhou Tumor(Fourth Peoples)Hospital

    Changzhou, Jiangsu, 213000, China

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310002, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Inner Mongolia Autonomous Region Cancer Hospital

    Hohhot, Inner Mongolia, 010028, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )

    Jieyang, Guangdong, 522000, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510000, China

  • The First Peoples Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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

    Wuhan, Hubei, 430022, China

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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