Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaPhase 2NCT07435454
Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing oral paclitaxel+radiotherapy in people with Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- oral paclitaxel+radiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
Nanjing, Jiangsu, 210000
Ning Jiang, +86 13605184783, njiang117@njmu.edu.cn
About this study
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.
Read the 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.
- Being tested
- oral paclitaxel+radiotherapy
- Keywords
- esophageal carcinoma, oral paclitaxel, radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral paclitaxel+radiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| oral paclitaxel combined with radiotherapy | Experimental | Not described Receives: Other: oral paclitaxel+radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from study enrollment up to 90 days after the completion of treatment
Secondary outcomes (4)
Progression- Free Survival
progression-free survival (PFS) defined as from study enrollment to tumor progression (in any aspect) or death from any cause
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Jiang, M.D./Ph.D., Jiangsu Cancer Institute & Hospital
- Investigators
- Xiangzhi Zhu, Study director, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435454
- Sponsor's protocol ID
- KY-2025-166
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07435454
- Acronym / sponsor ID
- KY-2025-166
- Keywords
- esophageal carcinoma, oral paclitaxel, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral paclitaxel combined with radiotherapy | Experimental | Other: oral paclitaxel+radiotherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral paclitaxel+radiotherapyOral 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. | Other | oral paclitaxel combined with radiotherapy |
Primary outcome
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.
4 secondary outcomes
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
Objective Response Rate
Time frame: 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
Disease Control Rate
Time frame: 3 months after the completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangzhi Zhu study director
Jiangsu Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral paclitaxel+radiotherapy in people with Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangzhi Zhu (+86 25 83283535, 13182948068@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: from study enrollment up to 90 days after the completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.