A Retrospective Study of Immunotherapy in Conversion Ther... | NCT05385809

Studies
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

NCT05385809

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Nov 9, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Unresectable Gastric Cancer

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jul 30, 2022Actual

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 17, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 23, 2022Actual

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

Nov 8, 2022

Last Update Posted Date

Nov 9, 2022Actual

Name	Class
Innovent Biologics, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.

Detailed Description

Not provided

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical conversion rate		two years

Secondary Outcomes

Measure	Description	Time Frame
R0 resection rate	Defined as no residue under the microscope after resection	two years
Major pathological response (MPR)	MPR is defined as less than 10% residual tumor after neoadjuvant therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages: 18-75 Years (concluding 18 and 75 Years)
Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
At least 1 measurable lesion by RECIST v1.1 criteria
ECOG PS: 0-2
Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle

Exclusion Criteria:

Known Her2 positive
Patients with incomplete data or other factors affecting the judgment of efficacy and safety

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

100 pantients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received immunotherapy prior to surgical resection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pengfei Yu, MD, PhD	Contact	86-571-88128031		ypfzmu@163.com

Overall Officials

Name	Affiliation	Role
Xiangdong Cheng, MD, PhD	Zhejiang Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Cancer Hospital	Recruiting	Hangzhou	Zhejiang	310022	China