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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

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Chengdu, Sichuan, China

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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: PCR,DFS,OS

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

  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
  • Patients with resectable or potentially resectable disease based on baseline clinical assessment.

Exclusion criteria

  • Presence of any untreated malignancy within the past five years, except fully treated cervical carcinoma in situ or basal cell carcinoma/squamous cell skin cancer.
  • Receipt of other neoadjuvant treatments, including chemotherapy, chemoradiotherapy, or chemoradiotherapy combined with immunotherapy.

Incomplete medical records.

  • Refusal to participate in follow-up.

Treatment and study plan

The cohort included 161 patients treated with solvent-based paclitaxel and 226 treated with nanoparticle albumin-bound paclitaxel.

Drug

Nab-P group

Intervention Type: Drug Intervention Name: Nab-paclitaxel Description: Patients had received nab-paclitaxel-based chemotherapy as part of neoadjuvant immunochemotherapy before esophagectomy. Treatment was administered as part of routine clinical care and was not assigned by the investigators for this retrospective observational study.

PTX group

Intervention Type: Drug Intervention Name: Paclitaxel Description: Patients had received paclitaxel-based chemotherapy as part of neoadjuvant immunochemotherapy before esophagectomy. Treatment was administered as part of routine clinical care and was not assigned by the investigators for this retrospective observational study.

Primary outcomes

  1. PCR

    Time frame: Within 4 weeks after surgery

    Pathological Complete Response

  2. DFS

    Time frame: From the date of esophagectomy until the date of first documented disease recurrence, disease progression, or death from any cause, whichever came first, assessed up to 60 months.

    disease-free survival

  3. OS

    Time frame: From the date of initial diagnosis of esophageal squamous cell carcinoma until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 60 months.

    overall survival

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Important dates

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