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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Other: oral paclitaxel+radiotherapy

Detailed Description

There remains a considerable unmet medical need for first-line treatment in patients with locally advanced, unresectable esophageal squamous cell carcinoma who are intolerant to concurrent intravenous chemotherapy and present with severe obstruction. Therefore, this prospective, single-arm, single-center exploratory study aims to evaluate the safety and efficacy of oral paclitaxel combined with radiotherapy in the treatment of locally advanced, unresectable esophageal squamous cell carcinoma, and to investigate the survival benefit provided for this patient population.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiangzhi Zhu; Phone Number: +86 25 83283535; Email: 13182948068@163.com
• Study Contact Backup: Name: Ning Jiang; Phone Number: +86 25 83283535; Email: njiang117@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
      • Contact: Ning Jiang; Phone Number: +86 13605184783; Email: njiang117@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cTXN+M0 or cT2-T4aNXM0).
2. Considered eligible for definitive chemoradiotherapy.
3. Age ≥ 70 years and/or intolerant to intravenous chemotherapy due to comorbidities, with severe dysphagia/feeding obstruction.
4. Disease evaluable by qualitative radiologic assessment per the local investigator.
5. Not eligible for curative surgery.
6. Adequate hematologic function, defined as: ANC ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
7. 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.
8. 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.
9. Adequate coagulation function, defined as: INR ≤ 1.5 × ULN, unless the patient is on anticoagulant therapy with PT or aPTT within the therapeutic range.
10. Negative urine or serum pregnancy test within 24 hours prior to the first dose of study intervention.
11. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.

Exclusion Criteria:

1. Direct tumor invasion into adjacent organs, such as the aorta or trachea (i.e., T4b disease).
2. Prior chemotherapy or radiotherapy for esophageal cancer.
3. Any prior systemic anticancer therapy for esophageal cancer.
4. Major surgery other than feeding tube insertion, open biopsy, or significant trauma within 28 days before randomization, or anticipated major surgery during study treatment.
5. History of other malignancy within the past 5 years, except carcinoma in situ of the cervix or basal cell carcinoma.
6. Gastric fistula or esophageal fistula.
7. Active infection requiring systemic therapy.
8. Known history of HIV, HBV, or HCV infection.
9. Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment.
10. History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis.
11. Known hypersensitivity to any study drug.
12. Inability or unwillingness to comply with protocol requirements as assessed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: oral paclitaxel combined with radiotherapy

Other: oral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression- Free Survival	progression-free survival (PFS) defined as from study enrollment to tumor progression (in any aspect) or death from any cause	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	Objective Response Rate (ORR) is defined as the proportion of subjects who achieve Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	3 months after the completion of treatment
Overall Survival	Defined as from date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first.	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	Disease Control Rate (DCR) is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	3 months after the completion of treatment

Collaborators and Investigators

• Sponsor: Jiangsu Cancer Institute & Hospital
• Investigators: Study Director: Xiangzhi Zhu, Jiangsu Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; oral paclitaxel; esophageal carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: KY-2025-166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No