Esophageal Arterial Infusion Chemotherapy Versus Systemic Intravenous Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Multicentre, Randomised Controlled Clinical Study

The First Affiliated Hospital of Zhengzhou University0 sites120 target enrollmentJune 1, 2022

ConditionsResectable Locally Advanced Esophageal Squamous Cell Carcinoma

InterventionsSystemic intravenous chemotherapy Esophageal arterial infusion chemotherapy

DrugsSystemic intravenous chemotherapy

Overview

Phase: Phase 2
Intervention: Systemic intravenous chemotherapy
Conditions: Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor: The First Affiliated Hospital of Zhengzhou University
Enrollment: 120
Primary Endpoint: Progression free survival (PFS)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This was a prospective, multicentre, randomised controlled clinical study to explore the safety and efficacy of esophageal arterial infusion chemotherapy in patients with resectable locally advanced oesophageal cancer, and to compare its safety and efficacy with systemic intravenous chemotherapy. The rate of surgical R0 resection as well as progression free survival (PFS) were the main indicators.

Registry

clinicaltrials.gov

Start Date

June 1, 2022

End Date

May 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The First Affiliated Hospital of Zhengzhou University

Responsible Party

Principal Investigator

Gang Wu

Chief physician

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent prior to the implementation of any test related procedures;
•Aged 18-75 years;
•Histopathological examination confirmed resectable esophageal carcinoma (histologically, squamous cell carcinoma), without esophageal/gastric junction adenocarcinoma;
•Before surgery, CT/MRI, color ultrasound, PET-CT, and ultrasonic gastroscopy were used to clearly diagnose esophageal cancer staging as \>= CT3 or \>=N+;
•Newly diagnosed patients without previous surgery, radiotherapy or chemotherapy, targeted therapy or immunotherapy;
•ECOG score ≤2，KPS ≥60%;
•No serious heart, lung or liver dysfunction; No acute infection was associated;
•No participation in other clinical studies within 3 months prior to treatment;
•Sufficient organ function, subject should meet the following laboratory criteria:
•The absolute value of neutrophils (ANC) ≥1.5x10\^9/L in the last 14 days without the use of granulocyte colony-stimulating factor;

Exclusion Criteria

•Previous operation history of thoracic malignant tumor;
•Pathologically small cell carcinoma or distant metastasis; Patients with tumor involvement of the cervical esophagus or high upper thoracic segment requiring laryngectomy;
•Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure \>140 mmHg, diastolic blood pressure \> 90 mmHg);
•Patients at high risk of bleeding or perforation due to tumor invasion of an adjacent organ of the esophageal lesion (aorta or trachea), or patients with fistula;
•Other malignant diseases other than esophageal cancer diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical resection, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection);
•Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
•Received Chinese patent drugs with anti-tumor indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for local use of pleural effusion control) within 2 weeks before the first administration;
•Known interstitial pulmonary disease requiring steroid therapy, active pulmonary tuberculosis, active autoimmune disease requiring systemic therapy (e.g., use of palliative drugs, glucocorticoids, or immunosuppressants) developed within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;
•The study was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological dose of glucocorticoids (≤10mg/ day of prednisone or equivalent drug) is allowed;
•Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;