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New treatment option for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Official title Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07435454
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join 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.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.