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.
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.
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.
Single group
oral paclitaxel+radiotherapy
Other interventionOral 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 occurrence of: disease progression (PD), intolerable toxicity, withdrawal of informed consent, treatment termination deemed necessary by the investigator, loss to follow-up, or death.
Adverse Event
Adverse Event (AE) is defined as any untoward medical occurrence in a subject participating in a clinical trial, which does not necessarily have a causal relationship with the study treatment, including any new sign, symptom, disease, or laboratory abnormality.
Progression- Free Survival
progression-free survival (PFS) defined as from study enrollment to tumor progression (in any aspect) or death from any cause
Objective Response Rate
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Overall Survival
Defined as from date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first.
Disease Control Rate
Disease Control Rate (DCR) is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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