New pill combo offers hope for Hard-to-Treat esophageal cancer
NCT ID NCT07435454
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
RECRUITINGNanjing, Jiangsu, 210000, China
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