Advanced Gastric CancerNCT06727981
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
An observational study of Advanced Gastric Cancer and Locally Advanced Gastric Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Gastric Cancer, Locally Advanced Gastric Carcinoma
- What is being tested?
- ICI plus Chemothearpy and Chemotherapy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 15 Jan 2028
- How long will I take part?
- 1 Year
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically defined, locally inoperable or advanced gastric cancer who have not received any previous anti-tumor therapy and are expected to receive immunotherapy.
Who may be able to join
- Age 18 years old or above
- Patients with advanced gastric cancer or locally advanced gastric cancer
- Have not received any previous anti-tumor therapy
- Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function
Who cannot join
- Patients with contraindications to immunotherapy
- Have received anti-tumor treatments such as immunotherapy and chemotherapy
- Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
- Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
- History of allogeneic stem cell transplantation or organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Song Li, MD contact
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Lian Liu, MD, 0531-82169851, tounao@126.com
Song Li, MD, 0531-82169851
About this study
Official title: Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
- Being tested
- ICI plus Chemothearpy, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICI plus ChemothearpyDrug
This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.
ChemotherapyDrug
This intervention involves the administration of standard chemotherapy alone.
| Study group | Role | What they receive |
|---|---|---|
| ICI plus chemotherapy | Not described Receives: Drug: ICI plus Chemothearpy | |
| Chemotherapy | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from the starting date of study drug to death
Measured: 12 months after the last subject participating in
Secondary outcomes (7)
Disease Control Rate (DCR) as assessed by RECIST1.1
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects.
Measured: 6 months after the last subject participating in
Duration of response (DOR) as assessed by RECIST1.1
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 12 months after the last subject participating in
Number of participants with treatment-related adverse events as assessed by CTCAE5.0
Incidence and severity of adverse effects associated with the treatments, categorized by type and grade according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: 12 months after the last subject participating in
Progression-free survival (PFS) as assessed by RECIST1.1
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 after the last subject participating in
Objective remission rate (ORR) as assessed by RECIST1.1
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 3 months after the last subject participating in
Disease-free survival (DFS) as assessed by RECIST1.1
The period from treatment until the occurrence of disease recurrence, progression, or death.
Measured: 36 months after the last subject participating in
Major pathological response (MPR)
he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy.
Measured: 3 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Jan 2022
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lian Liu, MD, PHD, Qilu Hospital of Shandong University
- Investigators
- Lian Liu, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727981
- Sponsor's protocol ID
- EABI-GC
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06727981
- Acronym / sponsor ID
- EABI-GC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 11 Dec 2024 (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 prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICI plus chemotherapy | – | Drug: ICI plus Chemothearpy |
| Chemotherapy | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically defined, locally inoperable or advanced gastric cancer who have not received any previous anti-tumor therapy and are expected to receive immunotherapy.
Key inclusion criteria (6 listed)
- Age 18 years old or above
- Patients with advanced gastric cancer or locally advanced gastric cancer
- Have not received any previous anti-tumor therapy
- Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (5 listed)
- Patients with contraindications to immunotherapy
- Have received anti-tumor treatments such as immunotherapy and chemotherapy
- Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
- Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
- History of allogeneic stem cell transplantation or organ transplantation
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 |
|---|---|---|
| ICI plus ChemothearpyThis intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy. | Drug | ICI plus chemotherapy |
| ChemotherapyThis intervention involves the administration of standard chemotherapy alone. | Drug | Chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: 12 months after the last subject participating in
The time from the starting date of study drug to death
7 secondary outcomes
Disease Control Rate (DCR) as assessed by RECIST1.1
Time frame: 6 months after the last subject participating in
Duration of response (DOR) as assessed by RECIST1.1
Time frame: 12 months after the last subject participating in
Number of participants with treatment-related adverse events as assessed by CTCAE5.0
Time frame: 12 months after the last subject participating in
Progression-free survival (PFS) as assessed by RECIST1.1
Time frame: 12 months after the last subject participating in
Objective remission rate (ORR) as assessed by RECIST1.1
Time frame: 3 months after the last subject participating in
Disease-free survival (DFS) as assessed by RECIST1.1
Time frame: 36 months after the last subject participating in
Major pathological response (MPR)
Time frame: 3 months after the last subject participating in
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Song Li, MD contact
Lian Liu, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Gastric Cancer and Locally Advanced Gastric Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lian Liu, MD (0531-82169851, tounao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 12 months after the last subject participating in). 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 11 Dec 2024.