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

NCT07435454 | Recruiting Phase 2

• 1 other identifier: KY-2025-166
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Keywords

esophageal carcinoma; oral paclitaxel; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  from study enrollment up to 90 days after the completion of treatment

Secondary Outcomes (4)

• Progression- Free Survival

  From date of enrollment until the date of tumor progression (in any aspect) or death from any cause, whichever came first, assessed up to 36 months

• Objective Response Rate

  3 months after the completion of treatment

• Overall Survival

  From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months

• Disease Control Rate

  3 months after the completion of treatment

Study Arms (1)

oral paclitaxel combined with radiotherapy

EXPERIMENTAL

Other: oral paclitaxel+radiotherapy

Interventions

oral paclitaxel+radiotherapy OTHER

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.

oral paclitaxel combined with radiotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Not eligible for curative surgery.
• Adequate hematologic function, defined as: ANC ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
• Adequate renal function, defined as: creatinine ≤ 1.5 × ULN; or for patients with creatinine \> 1.5 × ULN, measured or calculated creatinine clearance ≥ 60 mL/min.
• Adequate hepatic function, defined as: total bilirubin ≤ 1.5 × ULN; or for patients with total bilirubin \> 1.5 × ULN, direct bilirubin ≤ ULN provided ALT/AST ≤ 2.5 × ULN and albumin ≥ 3.0 g/dL.
• Adequate coagulation function, defined as: INR ≤ 1.5 × ULN, unless the patient is on anticoagulant therapy with PT or aPTT within the therapeutic range.
• Negative urine or serum pregnancy test within 24 hours prior to the first dose of study intervention.
• Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.

You may not qualify if:

• 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.
• History of other malignancy within the past 5 years, except carcinoma in situ of the cervix or basal cell carcinoma.
• Gastric fistula or esophageal fistula.
• Active infection requiring systemic therapy.
• Known history of HIV, HBV, or HCV infection.
• Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment.
• History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis.
• Known hypersensitivity to any study drug.
• Inability or unwillingness to comply with protocol requirements as assessed by the investigator.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Xiangzhi Zhu

  Jiangsu Cancer Institute & Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiangzhi Zhu

CONTACT

+86 25 83283535; 13182948068@163.com

Ning Jiang

CONTACT

+86 25 83283535; njiang117@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jiangsu Cancer Institute & Hospital

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)