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

February 25, 2026 updated by: Ning Jiang, M.D./Ph.D., Jiangsu Cancer Institute & Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: from study enrollment up to 90 days after the completion of treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression- Free Survival
Time Frame: 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
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
Time Frame: 3 months after the completion of treatment
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
Time Frame: 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
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
Time Frame: 3 months after the completion of treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Cancer Institute & Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiangzhi Zhu, Jiangsu Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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