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

NCT05381636 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

PROCEDURE

Esophageal arterial infusion chemotherapy

Percutaneous femoral artery puncture was performed to search for feeding arterial vessels corresponding to the lesion, and chemotherapeutic drugs were directly injected into the tumor vessels via targeted blood vessels.

DRUG

Systemic intravenous chemotherapy

Albumin paclitaxel 125 mg / m2, D1, D8 + cisplatin 75 mg / m2, D1, every 3 weeks for 1 cycle

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-06-01
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05381636 on ClinicalTrials.gov