Clinical trial · Interventional
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Phase II Study of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- 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)
Surgical resection is currently the major treatment for esophageal carcinoma while disease progression still occurred in most cases within 3 years. The rate of local recurrence and distant metastases could reach nearly 40% to 60%. The neoadjuvant chemotherapy could significantly improve resection rate and overall survival after surgery. Squamous cell carcinoma is the most common histology in Asia. JCOG9907 trial performed in Japan confirmed that compared to surgery plus adjuvant chemotherapy, the combination of neoadjuvant chemotherapy and surgery could further prolong overall survival. The regimen of cisplatin and fluorouracil is a classic effective option in combination therapy for esophageal carcinoma. Nanoparticle albumin-bound (nab)-paclitaxel is a novel taxane and has better efficacy in esophageal carcinoma treatment. We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin and capecitabine for locally advanced thoracic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy group
- description
- Total 6 perioperative chemotherapy composed of nab-paclitaxel, cisplatin and capecitabine every 21 days
- interventionNames
- Drug: nab-paclitaxel
- Drug: Cisplatin
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Pathological complete response (pCR) rate
- timeFrame
- 2 year
- description
- No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists
Secondary outcomes (9)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic pathological or cytological diagnosis of squamous cell carcinoma of esophagus * Age ranges from 18 to 70 years * Patients must not have received any prior anticancer therapy * Preoperative stage cT2N+M0, cT3-4aN0/N+M0 thoracic esophageal squamous cell carcinoma evaluated by MDT consultation based on imaging examinations * Eastern cooperative oncology group (ECOG) performance status of 0 to 1 * Signed informed consent document on file * Females with childbearing potential must have a negative serum pregnancy * Adequate organ function to receive esophagectomy including the following: Bone marrow: absolute white blood cells count ≥3.0×10\^9/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, haemoglobin ≥90g/L; Hepatic: total bilirubin ≤1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 times ULN; Renal: calculated creatinine clearance rate≥80ml/min * For childbearing potential males and females, who have agreed with contraception from start of investigational drug administration to 6 months after last dose of investigational drug * Patients who have no contraindication of nab-paclitaxel, cisplatin or capecitabine Exclusion Criteria: * Patients who may develop tracheoesophageal fistula or aortoesophageal fistula * Patients who have received allogeneic organ or stem cell transplants * Patients with uncontrolled diabetes mellitus, any serious or unstable medical condition or mental illness * Patients with preexisting or a history of ≥ Grade II peripheral neuropathy * Pregnant or breast feeding * Patients who take part in clinical trials of other drugs or biological therapy within 4 weeks before enrollment * Prior invasive malignancy in 5 years (except for curable carcinoma in situ of cervix and non-melanoma skin cancer) * Patients with digestive tract obstruction or metabolic dysfunction which may influence oral absorption of capecitabine * Patients with supraclavicular lymph node metastasis, celiac lymph node metastasis except for pericardial and left gastric lymph node metastasis * Patients with evidence of distant metastases
References
Publications (1)
- DERIVEDZhang W, Chen X, Xue L, Jiang Z, Qu D, Yang Z, Qin J, Wang Z, Zhang M, Li Y, Zhou A, Gao S. Neoadjuvant chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine for locally advanced esophageal squamous cell carcinoma: a phase 2 clinical trial. Int J Surg. 2025 Jun 1;111(6):3831-3837. doi: 10.1097/JS9.0000000000002375. Epub 2025 May 12. PMID 40358628