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

Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (NCT07435454) is a Phase 2 interventional studying Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, sponsored by Jiangsu Cancer Institute & Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 22 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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: white blood cell count (ANC) at least 1500/μL, platelet count ≥ 100,000/μL, and blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 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 willing to sign a consent form, good compliance, and willingness to comply with follow-up procedures. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07435454), the sponsor (Jiangsu Cancer Institute & Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07435454 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07435454?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07435454?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07435454. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07435454. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.