Advanced Gastric CancerNCT06376773
Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping.
An observational study of Advanced Gastric Cancer and Neoadjuvant Therapy, run by Fujian Medical University at 1 site in China.
Trial summary
Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Gastric Cancer, Neoadjuvant Therapy, Multi-omics Analysis
- What is being tested?
- combination chemotherapy with Apatinib or Camrelizumab
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Nov 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study collected data from 234 patients diagnosed with gastric adenocarcinoma at Fujian Medical University Union Hospital (FMUUH) who underwent gastrectomy after receiving neoadjuvant therapy (NAT) between January 2019 and January 2022.
Who may be able to join
- diagnosed with gastric adenocarcinoma and received neoadjuvant therapy
Who cannot join
- Patients with distant metastases, gastric stump cancer, or missing neoadjuvant chemotherapy data were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping: Chemotherapy, Immunotherapy, or Targeted Therapy? -A Retrospective Real-World Data Analysis
Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.
Read the detailed description
The advent of immunotherapy and targeted therapies has recently provided new options for AGC treatment. However, not all patients benefit from immunotherapy or targeted therapy, resulting in unsatisfactory overall treatment outcomes during the perioperative period. An ineffective treatment imposes significant financial burden, causes drug-related side effects that deteriorate their quality of life, and potentially delays subsequent treatment.
Evaluate the objective response rate (ORR) of the combination of camrelizumb, apatinib, and neoadjuvant chemotherapy for the treatment of advanced gastric patient Median survival time (OS);
Disease free survival time (DFS);
- Being tested
- combination chemotherapy with Apatinib or Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination chemotherapy with Apatinib or CamrelizumabProcedure or surgery
Also called mesenchymal, immunogenic, metabolic, classic
Apatinib, chemotherapy alone, Camrelizumab
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal | Based on RNA-seq transcriptome, patients were divided into mesenchymal, and received neoadjuvant chemotherapy with apatinib or not Receives: Procedure: combination chemotherapy with Apatinib or Camrelizumab | |
| immunogenic | Based on RNA-seq transcriptome, patients were divided into immunogenic, and received neoadjuvant chemotherapy with Camrelizumab or not Receives: Procedure: combination chemotherapy with Apatinib or Camrelizumab | |
| metabolic | Based on RNA-seq transcriptome, patients were divided into metabolic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not | |
| classic | Based on RNA-seq transcriptome, patients were divided into classic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival
Measured: 2years
Secondary outcomes (1)
objective response rate
objective response rate
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion30 Nov 2023
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 Fujian Medical 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
- Retrospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376773
- Sponsor's protocol ID
- 2022KY123
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping: Chemotherapy, Immunotherapy, or Targeted Therapy? -A Retrospective Real-World Data Analysis
- ClinicalTrials.gov ID
- NCT06376773
- Acronym / sponsor ID
- 2022KY123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Apr 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.
Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.
Detailed description
The advent of immunotherapy and targeted therapies has recently provided new options for AGC treatment. However, not all patients benefit from immunotherapy or targeted therapy, resulting in unsatisfactory overall treatment outcomes during the perioperative period. An ineffective treatment imposes significant financial burden, causes drug-related side effects that deteriorate their quality of life, and potentially delays subsequent treatment.
Evaluate the objective response rate (ORR) of the combination of camrelizumb, apatinib, and neoadjuvant chemotherapy for the treatment of advanced gastric patient Median survival time (OS);
Disease free survival time (DFS);
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mesenchymal | – | Procedure: combination chemotherapy with Apatinib or CamrelizumabBased on RNA-seq transcriptome, patients were divided into mesenchymal, and received neoadjuvant chemotherapy with apatinib or not |
| immunogenic | – | Procedure: combination chemotherapy with Apatinib or CamrelizumabBased on RNA-seq transcriptome, patients were divided into immunogenic, and received neoadjuvant chemotherapy with Camrelizumab or not |
| metabolic | – | –Based on RNA-seq transcriptome, patients were divided into metabolic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not |
| classic | – | –Based on RNA-seq transcriptome, patients were divided into classic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study collected data from 234 patients diagnosed with gastric adenocarcinoma at Fujian Medical University Union Hospital (FMUUH) who underwent gastrectomy after receiving neoadjuvant therapy (NAT) between January 2019 and January 2022.
Key inclusion criteria (1 listed)
- diagnosed with gastric adenocarcinoma and received neoadjuvant therapy
Key exclusion criteria (1 listed)
- Patients with distant metastases, gastric stump cancer, or missing neoadjuvant chemotherapy data were excluded from the study.
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 |
|---|---|---|
| combination chemotherapy with Apatinib or CamrelizumabAlso: mesenchymal, immunogenic, metabolic, classicApatinib, chemotherapy alone, Camrelizumab | Procedure or surgery | immunogenic, mesenchymal |
Primary outcome
overall survival
Time frame: 2years
overall survival
1 secondary outcome
objective response rate
Time frame: 6months
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 19 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoadjuvant Therapy, run by Fujian Medical 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 1 inclusion and 1 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 19 Apr 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?
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 (time frame: 2years). 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 19 Apr 2024.