RecruitingPhase 2NCT07435454

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


Sponsor

Jiangsu Cancer Institute & Hospital

Enrollment

22 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests oral paclitaxel (a chemotherapy drug taken by mouth) combined with radiotherapy in older or frail patients with locally advanced oesophageal squamous cell carcinoma who cannot tolerate standard intravenous chemotherapy. **You may be eligible if...** - You are 70 years or older, or younger but unable to tolerate standard IV chemotherapy due to other health conditions - You have locally advanced oesophageal squamous cell carcinoma (confirmed by biopsy) that cannot be surgically removed - You have significant difficulty swallowing or eating due to the tumour - You are considered suitable for definitive chemoradiotherapy (radiation plus chemotherapy as the main treatment) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are in very poor health and cannot tolerate any chemotherapy or radiation - You have recently received other cancer treatments that would interfere with this trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERoral 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 occurrence of: disease progression (PD), intolerable toxicity, withdrawal of informed consent, treatment termination deemed necessary by the investigator, loss to follow-up, or death.


Locations(1)

Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

Nanjing, Jiangsu, China

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NCT07435454


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