Oral paclitaxel combined with radiotherapy for locally advanced unresectable esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiangzhi Zhu
• Email: 13182948068@163.com
• Phone: +86 25 83283535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-course definitive chemoradiotherapy with camrelizumab for locally advanced unresectable esophageal squamous cell carcinoma

  This trial sees if adding camrelizumab to short-course chemoradiotherapy—given either during treatment and continued afterwards or given only as maintenance afterwards—improves tumor response and survival for adults with locally advanced unresectable esophageal squamous cell carcinoma.

  Recruiting Phase 2 Jiangsu Cancer Institute & Hospital · Nanjing, Jiangsu · NCT07530094

• Intensive nutrition during conversion therapy to enable surgery for locally advanced unresectable esophageal squamous cell carcinoma

  This will test whether giving intensive enteral nutrition alongside PD-1 inhibitor plus chemotherapy helps people with locally advanced unresectable esophageal squamous cell carcinoma achieve higher rates of complete tumor removal after conversion therapy.

  Recruiting Phase 2 Sichuan University · Chengdu, Sichuan · NCT07519486

• Interferon-gamma plus camrelizumab with chemotherapy before surgery for locally advanced esophageal squamous cell carcinoma

  This trial tests whether giving interferon-gamma with camrelizumab and chemotherapy before surgery helps patients with locally advanced esophageal squamous cell carcinoma.

  Recruiting at 2 sites Phase 2 Hefei Cancer Hospital of the Chinese Academy of Sciences · Hefei, Anhui and 1 other locations · NCT07787273

• Tislelizumab plus chemotherapy to convert unresectable locally advanced esophageal squamous cell carcinoma to surgery

  This study will try whether adding the immune drug tislelizumab to chemotherapy can shrink tumors so people with initially unresectable locally advanced esophageal squamous cell carcinoma can become eligible for surgery.

  Recruiting Shandong Provincial Hospital · Jinan, Shandong · NCT07549100

• Optimizing treatment for advanced esophageal cancer

  This study is testing a new treatment plan that combines chemotherapy, immunotherapy, and radiotherapy to see if it can help people with advanced esophageal cancer feel better and improve their chances of recovery.

  Recruiting Phase 2/3 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06907602

• Combining Toripalimab with Chemoradiotherapy for Esophageal Cancer

  This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with locally advanced esophageal cancer respond better to treatment before surgery.

  Recruiting Phase 2 Nanfang Hospital, Southern Medical University · Guangzhou, Baiyun District · NCT06843889

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.