Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced… (NCT07435454) | Clinical Trial Compass
RecruitingPhase 2
Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
China22 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
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.
✕
What they're measuring
1
Adverse Event
Timeframe: from study enrollment up to 90 days after the completion of treatment
. 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.