Esophageal CancerNCT07549269
Comparison of Nab-Paclitaxel Versus Paclitaxel in Neoadjuvant Immunochemotherapy Therapy for Esophageal Squamous Cell Carcinoma: A Retrospective IPTW-Adjusted Analysis
An observational study of Esophageal Cancer, run by Sichuan University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The cohort included 161 patients treated with solvent-based paclitaxel and 226 treated with nanoparticle albumin-bound paclitaxel.
- How many people
- 387 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2026to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
- Patients with resectable or potentially resectable disease based on baseline clinical assessment.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital
Chengdu, Sichuan
Mianzhu People's Hospital（West China Mianzhu Hospital, Sichuan University)
Mianzhu, Sichuan, 861916
Suining Central Hospital
Suining, Sichuan
About this study
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- The cohort included 161 patients treated with solvent-based paclitaxel and 226 treated with nanoparticle albumin-bound paclitaxel.
- Keywords
- ESCC, Neoadjuvant therapy, Nab-Paclitaxel, Paclitaxel
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Nab-P cohort | Not described Receives: Drug: The cohort included 161 patients treated with solvent-based paclitaxel and 226 treated with nanoparticle albumin-bound paclitaxel. | |
| PTX cohort | Not described Receives: Drug: The cohort included 161 patients treated with solvent-based paclitaxel and 226 treated with nanoparticle albumin-bound paclitaxel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR
Pathological Complete Response
Measured: Within 4 weeks after surgery
DFS
disease-free survival
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549269
- Sponsor's protocol ID
- Paclitax
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nab-Paclitaxel Versus Paclitaxel in Neoadjuvant Immunochemotherapy Therapy for Esophageal Squamous Cell Carcinoma: A Retrospective IPTW-Adjusted Analysis
- ClinicalTrials.gov ID
- NCT07549269
- Acronym / sponsor ID
- Paclitax
- Conditions
- Esophageal Cancer
- Keywords
- ESCC, Neoadjuvant therapy, Nab-Paclitaxel, Paclitaxel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
- Patients with resectable or potentially resectable disease based on baseline clinical assessment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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. | Drug | Nab-P cohort, PTX cohort |
Primary outcome
PCR
Time frame: Within 4 weeks after surgery
Pathological Complete Response
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Sichuan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR (time frame: Within 4 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.