The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell CarcinomaANACIIRE-1NCT06472635
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study
An observational study of The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Oct 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
- Hide hide Contacts/Locations
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 3210002
About this study
Official title: A Retrospective, Multicenter, Single-arm Real-world Study on a New Adjuvant Chemotherapy Combined With Immune Inhibitors for Resectable Esophageal Squamous Cell Carcinoma (ESCC)
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Mar 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengliang.Tu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472635
- Sponsor's protocol ID
- IIT20230408B-R2
- Acronym
- ANACIIRE-1
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter, Single-arm Real-world Study on a New Adjuvant Chemotherapy Combined With Immune Inhibitors for Resectable Esophageal Squamous Cell Carcinoma (ESCC)
- ClinicalTrials.gov ID
- NCT06472635
- Acronym / sponsor ID
- ANACIIRE-1 / IIT20230408B-R2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 25 Jun 2024 (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.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
- Hide hide Contacts/Locations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological Complete Response (pCR)
Time frame: 12 months
pCR is defined as the ratio of residual viable tumor cells being 0 in the primary tumor and sampled lymph nodes.
1 secondary outcome
Resection Rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma, run by Zhejiang University at 1 site 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Pathological Complete Response (pCR) (time frame: 12 months). 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 25 Jun 2024.