Oral paclitaxel combined with radiotherapy for 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

This trial will try taking oral paclitaxel together with radiotherapy to treat people with locally advanced, unresectable esophageal squamous cell carcinoma who are elderly or cannot tolerate intravenous chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Jiangsu Cancer Institute & Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07435454 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, single-center Phase 2 study testing oral paclitaxel given alongside definitive radiotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma. The trial enrolls patients who are aged 70 or older and/or those intolerant of intravenous chemotherapy, particularly those with severe dysphagia or feeding obstruction. The main focus is on safety and preliminary efficacy, with patients monitored for treatment-related toxicity, tumor response, and survival outcomes. The study aims to determine whether an oral formulation of paclitaxel can be a tolerable alternative to concurrent IV chemotherapy when combined with radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed locally advanced, unresectable esophageal squamous cell carcinoma who are age ≥70 and/or intolerant of intravenous chemotherapy, are not surgical candidates, have evaluable disease, and meet required organ-function criteria.

Not a fit: Patients who are eligible for curative surgery, have distant metastatic disease, or have inadequate hematologic, renal, hepatic, or coagulation function are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a more tolerable, effective treatment option that improves symptom control and survival for patients who cannot receive standard intravenous chemoradiotherapy.

How similar studies have performed: There is limited prior clinical experience with oral paclitaxel formulations and some early-phase data suggest activity in solid tumors, but combining oral paclitaxel with radiotherapy for unresectable esophageal squamous cell carcinoma is relatively novel and not yet widely validated.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiangzhi Zhu

Conditions Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma; esophageal carcinoma; oral paclitaxel; radiotherapy