Clinical trial · Interventional
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients
Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients
NCT01258192CI-TRIAL-00015244nabPCESCCcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albumin-bound paclitaxel plus cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel plus cisplatin
- interventionNames
- Drug: albumin-bound paclitaxel plus cisplatin
Primary outcomes (1)
- measure
- response to induction therapy
- timeFrame
- 2 years
- description
- The response to induction therapy will be evaluated
Secondary outcomes (4)
- measure
- rate of complete pathological response
- timeFrame
- 2 years
- description
- The rate of complete pathological response will be evaluated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram. * Age ranges from 18 to 70 years. * Patients must not have received any prior anticancer therapy. * Performance status of 0 to 1 * Estimated life expectancy of at least 6 months. * Tumor can be measured according to RECIST criteria * Signed informed consent document on file. * Females with childbearing potential must have a negative serum pregnancy * Adequate organ function including the following: Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment. Exclusion Criteria: * Carcinoma at the upper part of esophagus * Histologic diagnosis of adenocarcinoma of esophagus. * Prior treatment for esophageal cancer. * Active infection. * Pregnant or breast feeding. * History of significant neurological or mental disorder, including seizures or dementia. * Prior invasive malignancy in 5 years (except for carcinoma in situ).
References
Publications (1)
- DERIVEDFan Y, Jiang Y, Zhou X, Chen Q, Huang Z, Xu Y, Gong L, Yu H, Yang H, Liu J, Lei T, Zhao Q, Mao W. Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma. Oncotarget. 2016 Aug 2;7(31):50624-50634. doi: 10.18632/oncotarget.9562. PMID 27244882