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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorJiangsu Cancer Institute & Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • oral paclitaxel+radiotherapy

Treatment groups

22 Participants
are divided into 1 treatment group