Gastric Cancer Stage IVNCT07009600
Conversion Surgery After Target Therapy or Immunotherapy in Stage IV Gastric Cancer
An observational study of Gastric Cancer Stage IV, run by Samsung Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer Stage IV
- What is being tested?
- immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 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 Any age
- All sexes
- Child, Adult, Older 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.
Who may be able to join
- Stage IV gastric cancer patients who underwent conversion surgery
Who cannot join
- Patients who did not undergo gastrectomy
- Patients who underwent emergent surgery due to cancer perforation
- Patients with missing medical records or information
About this study
Official title: Impact of Targeted Therapy and Immune Checkpoint Inhibitors on Prognosis and Surgical Outcomes in Conversion Surgery for Stage IV Gastric Cancer
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).
- Conditions
- Gastric Cancer Stage IV
- Being tested
- immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival and disease free survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Eun Oh, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009600
- Sponsor's protocol ID
- SMC 2025-03-046-001
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Targeted Therapy and Immune Checkpoint Inhibitors on Prognosis and Surgical Outcomes in Conversion Surgery for Stage IV Gastric Cancer
- ClinicalTrials.gov ID
- NCT07009600
- Acronym / sponsor ID
- SMC 2025-03-046-001
- Conditions
- Gastric Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Jun 2025 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Stage IV gastric cancer patients who underwent conversion surgery
Key exclusion criteria (3 listed)
- Patients who did not undergo gastrectomy
- Patients who underwent emergent surgery due to cancer perforation
- Patients with missing medical records or information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immune check point inhibitors (PD-1 inhibitors), target therapy (trastuzumab) | Drug | – |
Primary outcome
overall survival and disease free survival
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
Related trials for Gastric Cancer Stage IV
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Not yet recruitingPhase 1
Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Stage IV, run by Samsung Medical Center.
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 3 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival and disease free survival (time frame: 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). 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 6 Jun 2025.