Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
Nanjing, Jiangsu, China, 210000
Actively Recruiting
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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