Actively Recruiting

Phase 2
Age: 70Years +
All Genders
NCT07435454

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

Led by Jiangsu Cancer Institute & Hospital · Updated on 2026-02-27

22

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cTXN+M0 or cT2-T4aNXM0)
  • Eligible for definitive chemoradiotherapy
  • Age 70 years or older and/or intolerant to intravenous chemotherapy due to other health conditions with severe swallowing difficulty
  • Disease can be evaluated by local radiologic assessment
  • Not eligible for curative surgery
  • Adequate blood function: ANC 1500/bcL, platelet count 100,000/bcL, hemoglobin 9.0 g/dL or 5.6 mmol/L
  • Adequate kidney function: creatinine 1.5 times ULN or creatinine clearance 60 mL/min if above this
  • Adequate liver function: total bilirubin 1.5 times ULN or direct bilirubin ULN if ALT/AST 2.5 times ULN and albumin 3.0 g/dL
  • Adequate blood clotting: INR 1.5 times ULN unless on anticoagulants with therapeutic PT or aPTT
  • Negative pregnancy test within 24 hours before first study dose
  • Voluntary participation with informed consent and willingness to follow study procedures
Not Eligible

You will not qualify if you...

  • Tumor directly invading nearby organs like the aorta or trachea (T4b disease)
  • Previous chemotherapy or radiotherapy for esophageal cancer
  • Any prior systemic anticancer therapy for esophageal cancer
  • Major surgery (except feeding tube insertion, open biopsy, or significant trauma) within 28 days before randomization or planned during treatment
  • History of other cancers within 5 years except certain skin or cervical cancers
  • Presence of gastric or esophageal fistulas
  • Active infections needing systemic treatment
  • Known HIV, HBV, or HCV infection
  • Participation in another investigational drug or device study within 4 weeks prior to treatment
  • History or current non-infectious pneumonitis requiring steroids
  • Known allergy to any study drug
  • Inability or unwillingness to follow study protocol as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

X

Xiangzhi Zhu

CONTACT

N

Ning Jiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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