Gastric Cancer, Gastroesophageal Junction CancerIMPACT-GCNCT06662110
IMmune Proteomics to Predict neoAdjuvant Chemotherapy and immunoTherapy Response in Gastric Cancer
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The overall efficacy of neoadjuvant treatment for advanced gastric cancer is limited due to significant heterogeneity in patient responses. While neoadjuvant therapy offers hope for improved clinical outcomes, the key challenge is accurately predicting individual treatment responses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- PSRscore
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Jun 2029
- How long will I take part?
- 3 Years
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Resectable gastric cancer patients who received neoadjuvant treatment followed by gastrectomy with D2 lymphadenectomy at Zhongshan Hospital, Fudan University
Who may be able to join
- Males or females aged 18 to 75 years;
- Newly diagnosed histologically confirmed gastric adenocarcinoma;
- Lesion located in the stomach or gastroesophageal junction as assessed by endoscopic ultrasound and enhanced CT, with clinical staging of T3-4NxM0 (based on the 8th edition of AJCC TNM classification);
- Determined suitable for neoadjuvant chemotherapy or neoadjuvant chemotherapy combined with immunotherapy after multidisciplinary consultation, with potential for curative resection post-treatment. The chemotherapy regimen is restricted to fluoropyrimidine and platinum-based systemic chemotherapy; the immunotherapy regimen is restricted to immune checkpoint inhibitors.
Who cannot join
- Prior receipt of any anti-tumor therapy for current gastric cancer or receipt of anti-tumor drugs for other conditions within the past 4 weeks;
- Presence of another malignancy or multiple primary tumors;
- Serious comorbidities with a life expectancy of less than 5 years;
- Severe chronic or active infections requiring systemic anti-infective therapy;
- Blood transfusion within the past week;
- Receipt of corticosteroid or immunosuppressive therapy within the past 2 weeks;
- Administration of a live vaccine within the past 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Xuhui District, Shanghai Municipality, 200032
Yuan Gu, M.D., 86+19533298320, gu.yuan@zs-hospital.sh.cn
About this study
Official title: A Prospective Cohort Study on Serum Immune Protein Signature for Predicting Neoadjuvant Therapy Efficacy in Advanced Gastric Cancer
The overall efficacy of neoadjuvant treatment for advanced gastric cancer is limited due to significant heterogeneity in patient responses. While neoadjuvant therapy offers hope for improved clinical outcomes, the key challenge is accurately predicting individual treatment responses. Identifying reliable biomarkers to guide treatment decisions is therefore critical. Immune factors are pivotal in the efficacy of gastric cancer treatment, but most research has predominantly focused on the tumor immune microenvironment. This study aims to validate the predictive value of systemic immune markers in predicting neoadjuvant treatment responses in advanced gastric cancer.
Building on our previous research, where we established a retrospective cohort of patients with advanced gastric cancer undergoing preoperative chemotherapy, we employed a novel serum proteomics platform based on proximity extension assays (PEA) to measure key immune protein levels in patient serum. This led to the development of the PSRscore system, a serum immune protein score that effectively predicted tumor regression after preoperative chemotherapy (published in Cell Reports Medicine, doi: 10.1016/j.xcrm.2023.100931).
Read more
In this prospective cohort study, we will enroll 166 patients with resectable advanced gastric cancer undergoing neoadjuvant chemotherapy. Baseline serum samples will be collected prior to treatment, and the PSRscore will be used to predict tumor regression. Pathological evaluation post-chemotherapy will confirm tumor response, helping to further validate and refine the PSRscore system. Additionally, an exploratory cohort of 40 patients receiving combined neoadjuvant chemotherapy and immunotherapy will be included to evaluate the correlation between PSRscore and clinical benefit from immunotherapy.
This research is expected to lead to the development of a predictive diagnostic kit based on the PSRscore for advanced gastric cancer patients undergoing neoadjuvant therapy, with the ultimate goal of improving clinical decision-making and enhancing treatment outcomes for gastric cancer patients.
- Being tested
- PSRscore
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSRscoreDiagnostic test
PSRscore calculated based on baseline serum immune proteomics
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy cohort | Resectable gastric cancer patients who received neoadjuvant chemotherapy, with the SOX regimen as the representative treatment plan, in accordance with standard clinical practice. Receives: Diagnostic Test: PSRscore | |
| neoadjuvant chemotherapy plus immunotherapy cohort | Resectable gastric cancer patients who received neoadjuvant chemotherapy plus immunotherapy in accordance with standard clinical practice. Receives: Diagnostic Test: PSRscore |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of PSRscore in predicting tumor regression after neoadjuvant therapy in patients with advanced gastric cancer
Measured: From enrollment to the end of the pathological examination of all resected tumor samples, an average of 2 years
Secondary outcomes (3)
the sensitivity and specificity of PSRscore in predicting objective response after neoadjuvant treatment in patients with advanced gastric cancer
Measured: From enrollment to the end of all the neo-adjuvant treatment, an average of 2 years
the sensitivity and specificity of PSRscore in predicting progression-free survival (PFS) after neoadjuvant treatment in patients with advanced gastric cancer
Measured: though study completion, an average of 5 years
the sensitivity and specificity of PSRscore in predicting overall survival (OS) after neoadjuvant treatment in patients with advanced gastric cancer
Measured: though study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer, Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 206 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuefei Wang, Principal investigator, Fudan UniversityZhaoqing Tang, Principal investigator, Fudan UniversityYuan Gu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662110
- Sponsor's protocol ID
- IMPACT-GC
- Acronym
- IMPACT-GC
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang Z, Gu Y, Shi Z, Min L, Zhang Z, Zhou P, Luo R, Wang Y, Cui Y, Sun Y, Wang X. Multiplex immune profiling reveals the role of serum immune proteomics in predicting response to preoperative chemotherapy of gastric cancer. Cell Rep Med. 2023 Feb 21;4(2):100931. doi: 10.1016/j.xcrm.2023.100931. Epub 2023 Jan 31.
PubMed 36724786
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Serum Immune Protein Signature for Predicting Neoadjuvant Therapy Efficacy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06662110
- Acronym / sponsor ID
- IMPACT-GC / IMPACT-GC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Oct 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.
The overall efficacy of neoadjuvant treatment for advanced gastric cancer is limited due to significant heterogeneity in patient responses. While neoadjuvant therapy offers hope for improved clinical outcomes, the key challenge is accurately predicting individual treatment responses. Identifying reliable biomarkers to guide treatment decisions is therefore critical. Immune factors are pivotal in the efficacy of gastric cancer treatment, but most research has predominantly focused on the tumor immune microenvironment. This study aims to validate the predictive value of systemic immune markers in predicting neoadjuvant treatment responses in advanced gastric cancer.
Building on our previous research, where we established a retrospective cohort of patients with advanced gastric cancer undergoing preoperative chemotherapy, we employed a novel serum proteomics platform based on proximity extension assays (PEA) to measure key immune protein levels in patient serum. This led to the development of the PSRscore system, a serum immune protein score that effectively predicted tumor regression after preoperative chemotherapy (published in Cell Reports Medicine, doi: 10.1016/j.xcrm.2023.100931).
In this prospective cohort study, we will enroll 166 patients with resectable advanced gastric cancer undergoing neoadjuvant chemotherapy. Baseline serum samples will be collected prior to treatment, and the PSRscore will be used to predict tumor regression. Pathological evaluation post-chemotherapy will confirm tumor response, helping to further validate and refine the PSRscore system. Additionally, an exploratory cohort of 40 patients receiving combined neoadjuvant chemotherapy and immunotherapy will be included to evaluate the correlation between PSRscore and clinical benefit from immunotherapy.
This research is expected to lead to the development of a predictive diagnostic kit based on the PSRscore for advanced gastric cancer patients undergoing neoadjuvant therapy, with the ultimate goal of improving clinical decision-making and enhancing treatment outcomes for gastric cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy cohort | – | Diagnostic Test: PSRscoreResectable gastric cancer patients who received neoadjuvant chemotherapy, with the SOX regimen as the representative treatment plan, in accordance with standard clinical practice. |
| neoadjuvant chemotherapy plus immunotherapy cohort | – | Diagnostic Test: PSRscoreResectable gastric cancer patients who received neoadjuvant chemotherapy plus immunotherapy in accordance with standard clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Resectable gastric cancer patients who received neoadjuvant treatment followed by gastrectomy with D2 lymphadenectomy at Zhongshan Hospital, Fudan University
Key inclusion criteria (4 listed)
- Males or females aged 18 to 75 years;
- Newly diagnosed histologically confirmed gastric adenocarcinoma;
- Lesion located in the stomach or gastroesophageal junction as assessed by endoscopic ultrasound and enhanced CT, with clinical staging of T3-4NxM0 (based on the 8th edition of AJCC TNM classification);
- Determined suitable for neoadjuvant chemotherapy or neoadjuvant chemotherapy combined with immunotherapy after multidisciplinary consultation, with potential for curative resection post-treatment. The chemotherapy regimen is restricted to fluoropyrimidine and platinum-based systemic chemotherapy; the immunotherapy regimen is restricted to immune checkpoint inhibitors.
Key exclusion criteria (7 listed)
- Prior receipt of any anti-tumor therapy for current gastric cancer or receipt of anti-tumor drugs for other conditions within the past 4 weeks;
- Presence of another malignancy or multiple primary tumors;
- Serious comorbidities with a life expectancy of less than 5 years;
- Severe chronic or active infections requiring systemic anti-infective therapy;
- Blood transfusion within the past week;
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 |
|---|---|---|
| PSRscorePSRscore calculated based on baseline serum immune proteomics | Diagnostic test | neoadjuvant chemotherapy cohort, neoadjuvant chemotherapy plus immunotherapy cohort |
Primary outcome
the sensitivity and specificity of PSRscore in predicting tumor regression after neoadjuvant therapy in patients with advanced gastric cancer
Time frame: From enrollment to the end of the pathological examination of all resected tumor samples, an average of 2 years
3 secondary outcomes
the sensitivity and specificity of PSRscore in predicting objective response after neoadjuvant treatment in patients with advanced gastric cancer
Time frame: From enrollment to the end of all the neo-adjuvant treatment, an average of 2 years
the sensitivity and specificity of PSRscore in predicting progression-free survival (PFS) after neoadjuvant treatment in patients with advanced gastric cancer
Time frame: though study completion, an average of 5 years
the sensitivity and specificity of PSRscore in predicting overall survival (OS) after neoadjuvant treatment in patients with advanced gastric cancer
Time frame: though study completion, an average of 5 years
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 28 Oct 2024.
- Results publication: PubMed 36724786Tang Z, Gu Y, Shi Z, Min L, Zhang Z, Zhou P, Luo R, Wang Y, Cui Y, Sun Y, Wang X. Multiplex immune profiling reveals the role of serum immune proteomics in predicting response to preoperative chemotherapy of gastric cancer. Cell Rep Med. 2023 Feb 21;4(2):100931. doi: 10.1016/j.xcrm.2023.100931. Epub 2023 Jan 31.
- 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.
Xuefei Wang principal investigator
Fudan University
Zhaoqing Tang principal investigator
Fudan University
Yuan Gu principal investigator
Fudan 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 Gastric Cancer, Gastroesophageal Junction Cancer, run by Shanghai Zhongshan Hospital 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 4 inclusion and 7 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 28 Oct 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 Xuefei Wang (+ 86 21 64041990, wang.xuefei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of PSRscore in predicting tumor regression after neoadjuvant therapy in patients with advanced gastric cancer (time frame: From enrollment to the end of the pathological examination of all resected tumor samples, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662110, which also lists 1 linked publication.
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 28 Oct 2024.