Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral paclitaxel+radiotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study aims to investigate the safety and efficacy of oral paclitaxel combined with radiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma.
Detailed description
There remains a considerable unmet medical need for first-line treatment in patients with locally advanced, unresectable esophageal squamous cell carcinoma who are intolerant to concurrent intravenous chemotherapy and present with severe obstruction. Therefore, this prospective, single-arm, single-center exploratory study aims to evaluate the safety and efficacy of oral paclitaxel combined with radiotherapy in the treatment of locally advanced, unresectable esophageal squamous cell carcinoma, and to investigate the survival benefit provided for this patient population.
Interventions
- Other oral paclitaxel+radiotherapy
Oral paclitaxel dosage:Administered twice daily (once each morning and evening), 200 mg/m² per administration. One cycle is 28 days, with dosing on Days 1, 8, and 15, for a total of 2 cycles. Radiotherapy:A total radiation dose of 50 Gy over 5 weeks (5 fractions per week). The decision to administer maintenance therapy will be based on tumor response, patient performance status, and the mutual agreement between the investigator and the patient. Treatment will continue until the earliest occur
Primary outcome measures
- Adverse Event [Time frame: from study enrollment up to 90 days after the completion of treatment]
Secondary outcome measures (4)
- Progression- Free Survival [Time frame: From date of enrollment until the date of tumor progression (in any aspect) or death from any cause, whichever came first, assessed up to 36 months]
- Objective Response Rate [Time frame: 3 months after the completion of treatment]
- Overall Survival [Time frame: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months]
- Disease Control Rate [Time frame: 3 months after the completion of treatment]
Eligibility criteria
Inclusion criteria
- Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cTXN+M0 or cT2-T4aNXM0).
- Considered eligible for definitive chemoradiotherapy.
- Age ≥ 70 years and/or intolerant to intravenous chemotherapy due to comorbidities, with severe dysphagia/feeding obstruction.
- Disease evaluable by qualitative radiologic assessment per the local investigator.
- Not eligible for curative surgery.
- Adequate hematologic function, defined as: ANC ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
- 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.
- 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.
- Adequate coagulation function, defined as: INR ≤ 1.5 × ULN, unless the patient is on anticoagulant therapy with PT or aPTT within the therapeutic range.
- Negative urine or serum pregnancy test within 24 hours prior to the first dose of study intervention.
- Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.
Exclusion criteria
- Direct tumor invasion into adjacent organs, such as the aorta or trachea (i.e., T4b disease).
- Prior chemotherapy or radiotherapy for esophageal cancer.
- Any prior systemic anticancer therapy for esophageal cancer.
- Major surgery other than feeding tube insertion, open biopsy, or significant trauma within 28 days before randomization, or anticipated major surgery during study treatment.
- History of other malignancy within the past 5 years, except carcinoma in situ of the cervix or basal cell carcinoma.
- Gastric fistula or esophageal fistula.
- Active infection requiring systemic therapy.
- Known history of HIV, HBV, or HCV infection.
- Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment.
- History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis.
- Known hypersensitivity to any study drug.
- Inability or unwillingness to comply with protocol requirements as assessed by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research — Nanjing
Identifiers
NCT: NCT07435454 · KY-2025-166