Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Prior treatment

• 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.
• Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment.

Other illness

• Direct tumor invasion into adjacent organs, such as the aorta or trachea (i.e., T4b disease).
• 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.
• History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis.
• Known hypersensitivity to any study drug.

Other

• Inability or unwillingness to comply with protocol requirements as assessed by the investigator.

• 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.