Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04390958 | Unknown Phase 2

• 1 other identifier: NCC-003475
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists

  2 year

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  2 year

• R0 resection rate

  2 year

• Major Pathological Response (MPR) rate

  2 year

• Overall survival (OS)

  From date of enrollment until the date of death from any cause, assessed up to 24 months

• Disease free survival (DFS)

  From date of enrollment until the date of death or recurrence, assessed up to 24 months

Study Arms (1)

Neoadjuvant chemotherapy group

EXPERIMENTAL

Total 6 perioperative chemotherapy composed of nab-paclitaxel, cisplatin and capecitabine every 21 days

Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Capecitabine

Interventions

nab-paclitaxel DRUG

125mg/m2 ivgtt d1、d8

Neoadjuvant chemotherapy group

Cisplatin DRUG

60mg/m2 ivgtt d1 or d1-2

Neoadjuvant chemotherapy group

Capecitabine DRUG

1750mg/m2 po bid d1-14

Neoadjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40358628 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Shugeng Gao, MD

  Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiping Zhou, MD

CONTACT

8613691161998; Zhouap1825@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

CN (1)