Gastric Cancer, Gastroesophageal Junction CancerNCT06814548
Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer and Immune Checkpoint Inhibitors (ICIs), run by Yongxu Jia.
Trial summary
This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer, Immune Checkpoint Inhibitors (ICIs), Second-line
- What is being tested?
- ICIs(Immune checkpoint inhibitors)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression.
Who may be able to join
- Histologically confirmed metastatic or advanced GC/GEJC;
- Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;
- Receiving at least 2 cycles of ICI-based second-line therapy;
- ECOG PS 0 or 1;
- Radiographic response was also assessed during treatment and survival.
Who cannot join
- patients had other malignancies within the past 5 years;
- lack of survival and clinical efficacy data;
- combined radiotherapy regimens in the second-line treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.
Read the detailed description
All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Immune Checkpoint Inhibitors (ICIs), Second-line, Retreatment
- Being tested
- ICIs(Immune checkpoint inhibitors)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIs(Immune checkpoint inhibitors)Other
N
| Study group | Role | What they receive |
|---|---|---|
| ICIs retreatment | Histologically confirmed metastatic or advanced GC/GEJC; Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting; Receiving at least 2 cycles of ICI-based second-line therapy; ECOG PS 0 or 1; Radiographic response was also assessed during treatment and survival. Receives: Other: ICIs(Immune checkpoint inhibitors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12 months
overall survival (OS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12 months
Secondary outcomes (3)
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 12 months
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects
Measured: 12 months
safety
Adverse events (AEs) were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
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 posted7 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongxu Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongxu Jia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814548
- Sponsor's protocol ID
- GC-2L-ICI-2024
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study
- ClinicalTrials.gov ID
- NCT06814548
- Acronym / sponsor ID
- GC-2L-ICI-2024
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Immune Checkpoint Inhibitors (ICIs), Second-line, Retreatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yongxu JiaUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 7 Feb 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.
This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.
Detailed description
All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICIs retreatment | – | Other: ICIs(Immune checkpoint inhibitors)Histologically confirmed metastatic or advanced GC/GEJC; Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting; Receiving at least 2 cycles of ICI-based second-line therapy; ECOG PS 0 or 1; Radiographic response was also assessed during treatment and survival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression.
Key inclusion criteria (5 listed)
- Histologically confirmed metastatic or advanced GC/GEJC;
- Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;
- Receiving at least 2 cycles of ICI-based second-line therapy;
- ECOG PS 0 or 1;
- Radiographic response was also assessed during treatment and survival.
Key exclusion criteria (3 listed)
- patients had other malignancies within the past 5 years;
- lack of survival and clinical efficacy data;
- combined radiotherapy regimens in the second-line treatment.
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 |
|---|---|---|
| ICIs(Immune checkpoint inhibitors)N | Other | ICIs retreatment |
Primary outcome
Progression-free survival (PFS)
Time frame: 12 months
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
overall survival (OS)
Time frame: 12 months
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
3 secondary outcomes
objective response rate (ORR)
Time frame: 12 months
disease control rate (DCR)
Time frame: 12 months
safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer and Immune Checkpoint Inhibitors (ICIs), run by Yongxu Jia.
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 5 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: opening soon, as of the sponsor's last update on 7 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongxu Jia Doctor (0371-66271156, jiayongxu111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 7 Feb 2025.