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New combo therapy before surgery shows promise for tough esophageal cancer

NCT ID NCT06764355

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new approach for people with locally advanced esophageal cancer. Participants first receive a combination of immunotherapy and chemotherapy, then chemoradiation, followed by surgery. The goal is to see if this sequence can shrink tumors more effectively and improve long-term outcomes. About 50 adults with squamous cell carcinoma of the esophagus are being recruited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

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

Started

Jul 2025

Expected to finish

Dec 2028

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 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.

Inclusion Criteria: 1. Pathologically proven squamous cell carcinoma of the intrathoracic esophagus. 2. Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by staging procedures (including but not limited to endoscopic ultrasound, computed tomography, bronchoscopy or positron emission tomography): 1. cT3/4a, N0, M0; 2. cT1-4a, N1-3, M0. 3. Tumor length longitudinal ≤ 10cm and radial ≤ 5cm. 4. The tumor must not extend more than 2cm into the stomach. 5. No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. 6. Age ≥ 18 and ≤ 75 years old. 7. Performance status ECOG 0\~1. 8. Adequate bone marrow reserves, defined as: 1. white blood cells (WBC) ≥ 3,000/µl or neutrophil count (ANC) ≥ 1,500/µl; 2. platelets ≥ 100,000/µl. 9. Adequate liver function reserves, defined as: 1. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); 2. serum total bilirubin ≤ 2.0 x upper limit of normal (ULN). 10. Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation) 11. Written informed consent. 12. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be mandatory. 13. Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section - Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. 14. Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Exclusion Criteria: 1. Adenocarcinoma 2. Previous thoracic irradiation 3. Previous systemic chemotherapy 4. Has received prior therapy with an anti-PD-1 or anti-PD-L1 5. Synchronous diagnosis of squamous cell carcinoma in the aerodigestive tract, other than esophageal cancer. 6. Prior malignancy, except for the following: 1. adequately treated basal cell or squamous cell skin cancer; 2. in-situ cervical cancer; 3. a "cured" malignancy more than 5 years prior to enrollment. 7. Significant co-morbid disease, which prohibits the conduction of immunochemotherapy, concurrent CRT, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders. 8. Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block. 9. Pre-existing motor or sensory neurotoxicity greater than grade 1. 10. Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine. 11. Weight loss \> 15%. 12. Dementia or altered mental status that would prohibit the understanding and completion of informed consent. 13. Estimated life expectancy less than 3 months. 14. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 15. Has a known history of active TB (Bacillus Tuberculosis) 16. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 17. Has known history of, or any evidence of active, non-infectious pneumonitis, interstitial lung disease or pulmonary fibrosis. 18. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 19. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 20. Patients with untreated chronic HBV or chronic HBV carriers whose HBV DNA is ≥500 IU/mL, or patients with active HCV. Patients who are inactive carriers or with treated and stable hepatitis B (detectable B surface antigen and HBV DNA \<500 IU/mL); patients with non-reactive HCV can be enrolled. Patients with chronic HBV infection need to be treated with anti-HBV agents while receiving immunochemotherapy and chemoradiotherapy according to the local and institutional guidelines. 21. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed. 22. Has received organ transplantation. 23. Has declined esophagectomy.

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100229, Taiwan

More trials for these conditions

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