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OpenTrials
Completed

NCT Number: NCT07549269

Comparison of Nab-Paclitaxel Versus Paclitaxel in Neoadjuvant Immunochemotherapy Therapy for Esophageal Squamous Cell Carcinoma: A Retrospective IPTW-Adjusted Analysis

Taxane-based agents are widely used in the treatment of esophageal squamous cell carcinoma (ESCC). Among these, nab-paclitaxel (albumin-bound paclitaxel) and paclitaxel are the most commonly used. However, there is currently no definitive evidence comparing the efficacy of these two agents in the context of neoadjuvant therapy for ESCC.

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Key information

About this study

Study Background Esophageal cancer is a common and rapidly progressing malignancy. Surgery, radiotherapy, and chemotherapy are the main treatments. Paclitaxel is a widely used chemotherapy drug, but conventional paclitaxel requires solvents that can cause allergic reactions and other side effects.

Albumin-bound paclitaxel (Nab-Paclitaxel) is a newer formulation that uses albumin nanoparticles to deliver the drug. This design reduces the need for solvents, improves drug distribution, may enhance effectiveness, and potentially lowers some side effects.

Study Purpose The study aimed to compare the effectiveness and safety of Nab-Paclitaxel versus standard Paclitaxel in neoadjuvant treatment of esophageal cancer, helping clinicians choose the most suitable regimen while providing patients with understandable treatment information.

Study Design Patient population: Patients receiving neoadjuvant chemotherapy for esophageal cancer

Treatment groups:

Nab-Paclitaxel + platinum-based chemotherapy Standard Paclitaxel + platinum-based chemotherapy

Study type: Retrospective analysis (examining completed patient data)

Key outcomes evaluated: Pathological response (TRS / PCR): Tumor shrinkage before surgery Surgical outcomes: e.g., R0 resection rate, Safety and side effects

Inclusion criteria

Pathologically confirmed ESCC, baseline assessment indicating resectable or potentially resectable disease, and receipt of at least one cycle of dual-agent chemotherapy (taxane + platinum) combined with immunotherapy (PD-1 or PD-L1 inhibitor).

Exclusion criteria

Presence of other untreated malignancies, receipt of other neoadjuvant treatments (such as chemotherapy alone, neoadjuvant chemoradiotherapy, or combined chemoradiotherapy-immunotherapy regimens), incomplete data, or unwillingness to participate in follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of any age with a histologically confirmed diagnosis of ESCC who were considered resectable or potentially resectable based on baseline assessment were eligible.

Exclusion criteria

Any untreated malignancy within the past five years (except fully treated cervical carcinoma in situ or basal/squamous cell skin cancer), receipt of other neoadjuvant treatments (chemotherapy, chemoradiotherapy, or chemoradiotherapy combined with immunotherapy), incomplete medical records, or refusal to participate in follow-up.

Treatment and study plan

Primary outcomes

  1. PCR

    Time frame: Within 4 weeks after surgery

    Pathological Complete Response

  2. DFS

    Time frame: From surgery to tumor progression or death

    disease-free survival

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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