Status:
UNKNOWN
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04390958
Start Date
May 15 2020
End Date
December 1 2022
Last Update
March 15 2022
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China