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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy group | Experimental | Total 6 perioperative chemotherapy composed of nab-paclitaxel, cisplatin and capecitabine every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | 125mg/m2 ivgtt d1、d8 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate | No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 year |
| R0 resection rate |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Zhou, MD | Contact | 8613691161998 | Zhouap1825@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shugeng Gao, MD | Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40358628 | Derived | Zhang 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. |
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| Cisplatin |
| Drug |
60mg/m2 ivgtt d1 or d1-2 |
|
| Capecitabine | Drug | 1750mg/m2 po bid d1-14 |
|
The ratio of the patients with surgical R0 resection over the of patients who receive surgery |
| 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 | 2 year |
| Overall survival (OS) | Time from enrollment to death | 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 | 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 | 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 | 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 | 2 year |
| Surgical complications | Within the first 90 days after the start of surgery |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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