Gastric CancerNCT05661110
Biomarker Analysis of HIPEC Combined With PD1/PDL1 Inhibitor for Gastric Cancer With Peritoneal Metastasis
An observational study of Gastric Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial summary
A single-center, observational study, integrated biomarker analysis of HIPEC combined Programmed cell death 1 /Programmed cell death 1 ligand 1(PD1/PDL1)inhibitor in previously treated patients of advanced gastric cancer with peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Observational
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2027
- 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: Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis
Who may be able to join
- Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
- Age 18-75 years, Male or Non-pregnant female
- Eastern Cooperative Oncology Group(ECOG): 0~1；
- Negative for human epidermal growth factor receptor 2(HER-2) by immunocytochemistry or fluorescence in situ hybridization；
- The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
- Patients had received HIPEC combined with PD1/PDL1 inhibitor conversion therapy.
- Signed the Informed Consent Form, and blood and tissue samples can be obtained;
Who cannot join
- Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
- Other patients who were considered unsuitable for inclusion by the researchers;
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
Official title: Integrated Biomarker Analysis for Hyperthermic Intraperitoneal Chemotherapy(HIPEC) Combined PD1/PDL1 Inhibitor Treatment in Patients of Advanced Gastric Cancer With Peritoneal Metastasis
A single-center, observational study, integrated biomarker analysis of HIPEC combined Programmed cell death 1 /Programmed cell death 1 ligand 1(PD1/PDL1)inhibitor in previously treated patients of advanced gastric cancer with peritoneal metastasis. Tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. This is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.
Read the detailed description
To analyze the correlation between genomic alterations, gene expression characteristics and the efficacy of HIPEC combined with PD1/PDL1 inhibitor conversion therapy in patients with peritoneal metastasis of gastric cancer. Circulating tumor DNA(ctDNA) in plasma samples and DNA, RNA in tumor tissue sample were obtained over the course of HIPEC combined PD1/PDL1 inhibitor conversion treatment will be assessed by high-intensity, next-generation sequencing(NGS) to identify genomic alterations. The assay will performed used AmoyDx® Master Panel(Amoy Diagnostics Co., Xiamen, China), which contains 559 genes for DNA mutation detection and 1813 genes for RNA expression and fusion detection. Data acquired will be analyzed to characterize the association between these genetic elements, clinical response, and durability of responses. There will be prospective groups for the study. Samples will be collected from patients in the prospective cohort who have been treated with HIPEC combined PD1/PDL1 inhibitor at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University under standard of conversion treatment.
- Conditions
- Gastric Cancer
- Being tested
- Observational
- Keywords
- Biomarker
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
All patients will be treated with standard of conversion treatment with HIPEC combined PD1/PDL1 inhibitor. After obtaining written informed consent, participants will have serial blood, tumor tissue collection. The blood collection (10 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. Participants will remain on the study for as long as they are being followed or treated at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University. Participants can withdraw from the study at any time.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Sample Collection | Prospective sample collection from participants treated with HIPEC combined PD1/PDL1inhibitor at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University under standard of care treatment. Blood and tissue samples will be collected prior to initiation of conversion therapy. And thereafter at the four time points: before and after surgery(±7 days), before the start of the second cycle of adjuvant, tumour progression, blood sample will be collected too. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between the status, numerical changes of ctDNA during HIPEC combined with PD1/PDL1 inhibitor conversion therapy and postoperative R0 resection rate.
R0 resection rate refers to the proportion of all patients with negative margins under the microscope of tumor specimens after surgery to the total number of participants. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during treatment.
Measured: 3 months
Secondary outcomes (4)
Genomic changes of ctDNA and see if they are predictive of ORR.
Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR))/total number of subjects ×100%. Measurable lesion according to the Response Evaluation Criteria In Solid Tumours(RECISTv1.1). To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during treatment.
Measured: 3 months
Genomic changes of ctDNA and see if they are predictive of overall survival time.
Overall survival time(OS) refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.
Measured: 2 years
Genomic changes of ctDNA and see if they are predictive of event-Free Survival.
Event-Free Survival(EFS): Defined as the interval between the first conversion therapy and the first recorded related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.
Measured: 2 years
Genomic changes of ctDNA and see if they are predictive of relapse-Free Survival.
Relapse-Free Survival(RFS): Defined as postoperative the first recorded postoperative recurrence of disease or death from any cause. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric 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
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuzhong Cui, Doctor, Principal investigator, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661110
- Sponsor's protocol ID
- HIPEC-11
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leal A, van Grieken NCT, Palsgrove DN, Phallen J, Medina JE, Hruban C, Broeckaert MAM, Anagnostou V, Adleff V, Bruhm DC, Canzoniero JV, Fiksel J, Nordsmark M, Warmerdam FARM, Verheul HMW, van Spronsen DJ, Beerepoot LV, Geenen MM, Portielje JEA, Jansen EPM, van Sandick J, Meershoek-Klein Kranenbarg E, van Laarhoven HWM, van der Peet DL, van de Velde CJH, Verheij M, Fijneman R, Scharpf RB, Meijer GA, Cats A, Velculescu VE. White blood cell and cell-free DNA analyses for detection of residual disease in gastric cancer. Nat Commun. 2020 Jan 27;11(1):525. doi: 10.1038/s41467-020-14310-3.
PubMed 31988276Wang D, Cabalag CS, Clemons NJ, DuBois RN. Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer. Gastroenterology. 2021 Dec;161(6):1813-1829. doi: 10.1053/j.gastro.2021.09.059. Epub 2021 Oct 2.
PubMed 34606846Smyth EC, Gambardella V, Cervantes A, Fleitas T. Checkpoint inhibitors for gastroesophageal cancers: dissecting heterogeneity to better understand their role in first-line and adjuvant therapy. Ann Oncol. 2021 May;32(5):590-599. doi: 10.1016/j.annonc.2021.02.004. Epub 2021 Feb 17.
PubMed 33609722
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Biomarker Analysis for Hyperthermic Intraperitoneal Chemotherapy(HIPEC) Combined PD1/PDL1 Inhibitor Treatment in Patients of Advanced Gastric Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT05661110
- Acronym / sponsor ID
- HIPEC-11
- Conditions
- Gastric Cancer
- Keywords
- Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Dec 2022 (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.
A single-center, observational study, integrated biomarker analysis of HIPEC combined Programmed cell death 1 /Programmed cell death 1 ligand 1(PD1/PDL1)inhibitor in previously treated patients of advanced gastric cancer with peritoneal metastasis. Tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. This is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.
Detailed description
To analyze the correlation between genomic alterations, gene expression characteristics and the efficacy of HIPEC combined with PD1/PDL1 inhibitor conversion therapy in patients with peritoneal metastasis of gastric cancer. Circulating tumor DNA(ctDNA) in plasma samples and DNA, RNA in tumor tissue sample were obtained over the course of HIPEC combined PD1/PDL1 inhibitor conversion treatment will be assessed by high-intensity, next-generation sequencing(NGS) to identify genomic alterations. The assay will performed used AmoyDx® Master Panel(Amoy Diagnostics Co., Xiamen, China), which contains 559 genes for DNA mutation detection and 1813 genes for RNA expression and fusion detection. Data acquired will be analyzed to characterize the association between these genetic elements, clinical response, and durability of responses. There will be prospective groups for the study. Samples will be collected from patients in the prospective cohort who have been treated with HIPEC combined PD1/PDL1 inhibitor at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University under standard of conversion treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Sample Collection | – | Other: ObservationalProspective sample collection from participants treated with HIPEC combined PD1/PDL1inhibitor at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University under standard of care treatment. Blood and tissue samples will be collected prior to initiation of conversion therapy. And thereafter at the four time points: before and after surgery(±7 days), before the start of the second cycle of adjuvant, tumour progression, blood sample will be collected too. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis
Key inclusion criteria (7 listed)
- Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
- Age 18-75 years, Male or Non-pregnant female
- Eastern Cooperative Oncology Group(ECOG): 0~1；
- Negative for human epidermal growth factor receptor 2(HER-2) by immunocytochemistry or fluorescence in situ hybridization；
- The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
Key exclusion criteria (2 listed)
- Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
- Other patients who were considered unsuitable for inclusion by the researchers;
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 |
|---|---|---|
| ObservationalAll patients will be treated with standard of conversion treatment with HIPEC combined PD1/PDL1 inhibitor. After obtaining written informed consent, participants will have serial blood, tumor tissue collection. The blood collection (10 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. Participants will remain on the study for as long as they are being followed or treated at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University. Participants can withdraw from the study at any time. | Other | Prospective Sample Collection |
Primary outcome
Relationship between the status, numerical changes of ctDNA during HIPEC combined with PD1/PDL1 inhibitor conversion therapy and postoperative R0 resection rate.
Time frame: 3 months
R0 resection rate refers to the proportion of all patients with negative margins under the microscope of tumor specimens after surgery to the total number of participants. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during treatment.
4 secondary outcomes
Genomic changes of ctDNA and see if they are predictive of ORR.
Time frame: 3 months
Genomic changes of ctDNA and see if they are predictive of overall survival time.
Time frame: 2 years
Genomic changes of ctDNA and see if they are predictive of event-Free Survival.
Time frame: 2 years
Genomic changes of ctDNA and see if they are predictive of relapse-Free Survival.
Time frame: 2 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 22 Dec 2022.
- Background: PubMed 31988276Leal A, van Grieken NCT, Palsgrove DN, Phallen J, Medina JE, Hruban C, Broeckaert MAM, Anagnostou V, Adleff V, Bruhm DC, Canzoniero JV, Fiksel J, Nordsmark M, Warmerdam FARM, Verheul HMW, van Spronsen DJ, Beerepoot LV, Geenen MM, Portielje JEA, Jansen EPM, van Sandick J, Meershoek-Klein Kranenbarg E, van Laarhoven HWM, van der Peet DL, van de Velde CJH, Verheij M, Fijneman R, Scharpf RB, Meijer GA, Cats A, Velculescu VE. White blood cell and cell-free DNA analyses for detection of residual disease in gastric cancer. Nat Commun. 2020 Jan 27;11(1):525. doi: 10.1038/s41467-020-14310-3.
- Background: PubMed 34606846Wang D, Cabalag CS, Clemons NJ, DuBois RN. Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer. Gastroenterology. 2021 Dec;161(6):1813-1829. doi: 10.1053/j.gastro.2021.09.059. Epub 2021 Oct 2.
- Background: PubMed 33609722Smyth EC, Gambardella V, Cervantes A, Fleitas T. Checkpoint inhibitors for gastroesophageal cancers: dissecting heterogeneity to better understand their role in first-line and adjuvant therapy. Ann Oncol. 2021 May;32(5):590-599. doi: 10.1016/j.annonc.2021.02.004. Epub 2021 Feb 17.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Shuzhong Cui, Doctor principal investigator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
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 7 inclusion and 2 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 22 Dec 2022. 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 Ziying Lei, Doctor ((086)020-66673666 ext. 3772, leiziyinggz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between the status, numerical changes of ctDNA during HIPEC combined with PD1/PDL1 inhibitor conversion therapy and postoperative R0 resection rate. (time frame: 3 months). 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 NCT05661110, which also lists 3 linked publications.
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 22 Dec 2022.