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New pill combo offers hope for Hard-to-Treat esophageal cancer

NCT ID NCT07435454

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether a chemotherapy pill (oral paclitaxel) combined with radiation can safely treat advanced esophageal cancer that cannot be removed by surgery. It is for people aged 70 or older, or those who cannot tolerate standard IV chemo. The goal is to control the disease and improve symptoms, not to cure it.

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 22 people

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

Started

Dec 2025

Expected to finish

Dec 2027

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

70 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: 1. Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cTXN+M0 or cT2-T4aNXM0). 2. Considered eligible for definitive chemoradiotherapy. 3. Age ≥ 70 years and/or intolerant to intravenous chemotherapy due to comorbidities, with severe dysphagia/feeding obstruction. 4. Disease evaluable by qualitative radiologic assessment per the local investigator. 5. Not eligible for curative surgery. 6. Adequate hematologic function, defined as: ANC ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. 7. Adequate renal function, defined as: creatinine ≤ 1.5 × ULN; or for patients with creatinine \> 1.5 × ULN, measured or calculated creatinine clearance ≥ 60 mL/min. 8. Adequate hepatic function, defined as: total bilirubin ≤ 1.5 × ULN; or for patients with total bilirubin \> 1.5 × ULN, direct bilirubin ≤ ULN provided ALT/AST ≤ 2.5 × ULN and albumin ≥ 3.0 g/dL. 9. Adequate coagulation function, defined as: INR ≤ 1.5 × ULN, unless the patient is on anticoagulant therapy with PT or aPTT within the therapeutic range. 10. Negative urine or serum pregnancy test within 24 hours prior to the first dose of study intervention. 11. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures. Exclusion Criteria: 1. Direct tumor invasion into adjacent organs, such as the aorta or trachea (i.e., T4b disease). 2. Prior chemotherapy or radiotherapy for esophageal cancer. 3. Any prior systemic anticancer therapy for esophageal cancer. 4. Major surgery other than feeding tube insertion, open biopsy, or significant trauma within 28 days before randomization, or anticipated major surgery during study treatment. 5. History of other malignancy within the past 5 years, except carcinoma in situ of the cervix or basal cell carcinoma. 6. Gastric fistula or esophageal fistula. 7. Active infection requiring systemic therapy. 8. Known history of HIV, HBV, or HCV infection. 9. Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment. 10. History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis. 11. Known hypersensitivity to any study drug. 12. Inability or unwillingness to comply with protocol requirements as assessed by the investigator.

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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

  • Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

    RECRUITING

    Nanjing, Jiangsu, 210000, China

More trials for these conditions

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