Clinical trial · Interventional
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This clinical trial was closed due to slow recruitment of patients.
Summary
Brief summary (as posted)
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Esophagus | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nanoparticle albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nanoparticle albumin-bound paclitaxel
- description
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
Primary outcomes (1)
- measure
- response rate
- timeFrame
- From date of treatment until the date of progression, assessed up to 2 months
- description
- pathological response rate and clinical response rate
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) * Locally advanced disease that is technically operable with curative intent (R0) * T3, N0 OR T1-3, N+ OR T4, Nx * No T1-2, N0 * No inoperable T4 (unequivocal organ involvement) * No distant metastasis, including M1a lymph node status * Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology * No carcinoma of the cervical esophagus * Obstructive tumors allowed Exclusion Criteria: * Not suitable to surgery * cervical Esophageal Carcinoma(distance of incisor tooth\<19cm) * early Esophageal Carcinoma(Stage I) * complete esophageal obstruction，Esophageal perforation or hematemesis * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * History of serious allergic or castor oil allergy * Patients who are not suitable to participate in the trial according to researchers
References
Publications (0)
Data not yet available