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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07549269
Enrollment
387
Registered
2026-04-24
Start date
2026-04-01
Completion date
2026-08-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

ESCC, Neoadjuvant therapy, Nab-Paclitaxel, Paclitaxel

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.

Detailed description

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.

Interventions

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

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.

Sponsors

Sichuan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC). 2. Patients with resectable or potentially resectable disease based on baseline clinical assessment.

Exclusion criteria

1. 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. 2. Receipt of other neoadjuvant treatments, including chemotherapy, chemoradiotherapy, or chemoradiotherapy combined with immunotherapy. Incomplete medical records. 3. Refusal to participate in follow-up.

Design outcomes

Primary

MeasureTime frameDescription
PCRWithin 4 weeks after surgeryPathological Complete Response
DFSFrom 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
OSFrom 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026