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

NCT ID: NCT04390958

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant chemotherapy group

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

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: DRUG

125mg/m2 ivgtt d1、d8

Cisplatin

Intervention Type: DRUG

60mg/m2 ivgtt d1 or d1-2

Capecitabine

Intervention Type: DRUG

1750mg/m2 po bid d1-14

Interventions

nab-paclitaxel

125mg/m2 ivgtt d1、d8

Intervention Type: DRUG

Cisplatin

60mg/m2 ivgtt d1 or d1-2

Intervention Type: DRUG

Capecitabine

1750mg/m2 po bid d1-14

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aiping Zhou

Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shugeng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Aiping Zhou, MD

Role: CONTACT

Zhouap1825@126.com

8613691161998

Facility Contacts

Zhou Aiping

Role: primary

zhouap1825@126.com

+86 13691161998

References

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.

Reference Type: DERIVED

PMID: 40358628 (View on PubMed)

Other Identifiers

NCC-003475

Identifier Type: -

Identifier Source: org_study_id