Conversion Surgery After Target Therapy or Immunotherapy... | NCT07009600

Studies
Conversion Surgery After Target Therapy or Immunotherapy in Stage IV Gastric Cancer

NCT07009600

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jun 6, 2025Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Gastric Cancer Stage IV

Interventions

immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)

Countries

Not provided

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 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

May 23, 2025

First Submission Date that Met QC Criteria

Jun 3, 2025

First Posted Date

Jun 6, 2025Actual

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 3, 2025

Last Update Posted Date

Jun 6, 2025Actual

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

In this retrospective study, investigators conducted a comprehensive investigation of the factors influencing postoperative prognosis in patients with stage IV gastric cancer undergoing conversion surgery. Specifically, investigators examined the impact of targeted therapy or immune check point inhibitors (ICIs) in combination with preoperative chemotherapy on (1) prognostic differences based on initial progression (invading adjacent organs) and metastatic site (peritoneum, distant lymph node [LN]) at the time of stage IV gastric cancer diagnosis and (2) conversion surgery outcomes and pathological complete response (pCR).

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

124Actual

Name	Type	Description	Arm Group Labels	Other Names
immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival and disease free survival		from date of surgery until the date of first documented cancer recurrence or date of death from cancer progression, whichever came first, assessed up to 160 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage IV gastric cancer patients who underwent conversion surgery

Exclusion Criteria:

Patients who did not undergo gastrectomy
Patients who underwent emergent surgery due to cancer perforation
Patients with missing medical records or information

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with clinically diagnosed and histologically confirmed stage IV gastric cancer between January 2010 and August 2024 and received systemic palliative-intent chemotherapy as initial treatment and underwent conversion surgery at Samsung Medical Center.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082082	Immune Checkpoint Inhibitors
D000068878	Trastuzumab

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000074322	Antineoplastic Agents, Immunological

Browse Leaves

Not provided

Browse Branches

Not provided