a Neo-adjuvant Chemotherapy Immunotherapy in Resectable E... | NCT06472635

Studies
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study

NCT06472635

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

Jun 25, 2024Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Oct 31, 2024Estimated

First Submitted Date

Jun 16, 2024

First Submission Date that Met QC Criteria

Jun 24, 2024

First Posted Date

Jun 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2024

Last Update Posted Date

Jun 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 months

Secondary Outcomes

Measure	Description	Time Frame
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.	12 months

Other Outcomes

Measure	Description	Time Frame
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.	12 months

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of Zhejiang University		Hangzhou	Zhejiang	3210002	China