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New hope for esophageal cancer: combining chemoradiation with immunotherapy

NCT ID NCT04821778

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is looking at the best way to treat esophageal cancer that cannot be removed by surgery. It will follow 2,000 patients who receive chemoradiotherapy (radiation plus chemotherapy) along with possible immunotherapy or targeted drugs. The goal is to see which combinations help people live longer and with fewer side effects.

What this could mean

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

Active substance
Radiotherapy, platinum-based chemotherapy, paclitaxel-based chemotherapy, anti-PD-1/PD-L1 immunotherapy, 5-FU analog chemotherapy, nimotuzumab
What this could lead to
If successful, this study could identify the best combination of chemoradiotherapy, immunotherapy, and targeted drugs to improve survival for people with advanced esophageal cancer.
What could go wrong
This is an observational cohort study, not a randomized trial, so results may not prove which treatment is best. Side effects from combined treatments can be serious.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2002

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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； * Esophageal or Esophagogastric cancer； * Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)； * Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences； * ECOG PS score: 0\~1； * Estimated survival time ≥3 months； * Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit； * Informed consent； Exclusion Criteria: * With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc； * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer； * Existing active infection such as active tuberculosis and hepatitis； * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia； * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin； * Participation in other clinical trials currently or within 4 weeks of selection； * Pregnant or lactating females； * Absence of medical records.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity esophageal cancer Esophageal Neoplasms gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Chemoradiation Chemotherapy effect Esophagogastric junction cancer Esophagus cancer Immunotherapy Targeted therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department 4th of Radiation Oncology, Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, 455001, China

  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

    RECRUITING

    Beijing, 100021, China

  • Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    RECRUITING

    Changsha, Hunan, 410031, China

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