NCT07549269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

April 9, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

ESCCNeoadjuvant therapyNab-Paclitaxel, Paclitaxel

Outcome Measures

Primary Outcomes (3)

  • PCR

    Pathological Complete Response

    Within 4 weeks after surgery

  • DFS

    disease-free survival

    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.

  • OS

    overall survival

    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.

Study Arms (2)

Nab-P cohort

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

PTX cohort

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

Interventions

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.

Nab-P cohortPTX cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study included 1877 ESCC patients who underwent esophagectomy at West China Hospital of Sichuan University and two other centers between June 2019 and December 2024. After screening, 387 eligible patients were included.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West China Hospital

Chengdu, Sichuan, China

Location

Mianzhu People's Hospital(West China Mianzhu Hospital, Sichuan University)

Mianzhu, Sichuan, 861916, China

Location

Suining Central Hospital

Suining, Sichuan, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Taxes

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 24, 2026

Study Start

April 1, 2026

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations