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Active, not recruitingNCT06472635ANACIIRE-1Updated Jun 25, 2024

a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study

An observational study in The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma, sponsored by Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
95
Ages
18 Years to 90 Years
Sex
All
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Study summary

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Read the detailed description

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

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Conditions studied

  • The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 95 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Esophageal Squamous Cell Carcinoma (ESCC), with a follow-up cutoff date of March 2024, is expected to take 6 months for data cleaning and analysis, and the data collection and analysis are anticipated to be completed in September 2024.

Inclusion criteria

Age ≥ 18 years (including 18 years old); ECOG 0 or 1; Patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher Received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery Clinical staging belongs to: T1b-4NanyM0;

Exclusion criteria

Exclusion Criteria:

Patients without complete medical information; Received other anti-tumor treatment before surgery; Received radiotherapy treatment; Judged by the researcher, have other conditions unsuitable for participating in this clinical study.

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05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
95 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Pathological Complete Response (pCR)

    pCR is defined as the ratio of residual viable tumor cells being 0 in the primary tumor and sampled lymph nodes.

    Time frame: 12 months

Secondary outcomes

  1. Resection Rate

    R0 resection refers to the complete removal of the tumor, with negative microscopic margins, indicating no residual tumor; no cancer cells are found on the cutting line under pathological examination.

    Time frame: 12 months

Other outcomes

  1. ORR

    Defined as the proportion of patients achieving complete response (CR) or partial response (PR) among all patients, with efficacy evaluation based on the RECIST 1.1 criteria.

    Time frame: 12 months

07

Study locations

1 site
  • The first affiliated hospital of Zhejiang University
    Hangzhou, Zhejiang 3210002, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06472635
Lead sponsor
Zhejiang University
Responsible party
Zhengliang.Tu (Director of General Thoracic Surgery Department / Chief Doctor, Zhejiang University) — Principal investigator
First posted
Jun 25, 2024
Start date
Mar 1, 2022
Primary completion
Sep 30, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Jun 25, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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