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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
125mg/m2 ivgtt d1、d8
60mg/m2 ivgtt d1 or d1-2
1750mg/m2 po bid d1-14
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGPathological complete response (pCR) rate
No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists
Time frame: 2 year
Objective Response Rate (ORR)
Objective response rate is defined as the rate of patients with at least a 30% decrease in the sum of the LD (longest diameter) of target lesions, which include complete response (CR) or partial response (PR)
Time frame: 2 year
R0 resection rate
The ratio of the patients with surgical R0 resection over the of patients who receive surgery
Time frame: 2 year
Major Pathological Response (MPR) rate
MPR is defined as 10% or fewer viable cancer cells in the hematoxylin and eosin (H\&E)-stained slides from the resected tumor following neoadjuvant treatment
Time frame: 2 year
Overall survival (OS)
Time from enrollment to death
Time frame: From date of enrollment until the date of death from any cause, assessed up to 24 months
Disease free survival (DFS)
From the day of surgery with R0 resection to recurrence or death of any reasons
Time frame: From date of enrollment until the date of death or recurrence, assessed up to 24 months
Progression-free survival (PFS)
number of participant with disease progression
Time frame: From date of enrolment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months
Recurrence rate
number of participant with disease recurrence
Time frame: 2 year
Treatment-emergent adverse events
From the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. To evaluate the incidence of TEAE, rate of grade 3 and 4 TEAE (CTCAE 5.0), rate of surgery delay over 30 days and/or inoperable patients
Time frame: 2 year
Surgical complications
Time frame: Within the first 90 days after the start of surgery
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