Advanced Gastric CarcinomaNCT06642857
Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastroesophageal Junction Cancer.
An observational study of Advanced Gastric Carcinoma and Advanced Gastroesophageal Junction Adenocarcinoma, run by Xiangdong Cheng at 1 site in China.
Trial summary
In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Peripheral blood, tougue coating, saliva, and feces
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 1 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Who may be able to join
- Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathology and with advanced or metastatic disease that cannot be resected
- HER2 negative
- Not received any anti-tumor treatment before.
- After evaluation, the treatment plan is chemotherapy combined with immunotherapy.
- Aged 18 to 75 years old, gender is not limited.
- Expected survival time is greater than or equal to 3 months. Exclusion criteria：
Show all 13Show fewer
- Patients with malignant tumors other than gastric cancer or those with tumors metastasized to the stomach from other sites.
- Patients who have previously received anti-tumor treatments such as surgery, radiotherapy and chemotherapy, targeted therapy or immunotherapy.
- Patients with severe infections.
- Those with a history of mental illness cannot cooperate with the research.
- Patients with severe heart, liver, kidney and other diseases.
- Pregnant or lactating patients.
- HER2 positive.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310000
Xiangdong Cheng Xiangdong Cheng, PhD, +0086-0571-88128041, chengxd516@126.com
Nannan Zhang Nannan Zhang, PhD, 18920166859, natilen@163.com
About this study
Official title: Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/gastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.
In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers/dominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric/gastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric/gastroesophageal junction cancer.
Read the detailed description
Main objective: to extract and identify multi omics information tags related to the efficacy of immunotherapy for advanced gastric / gastroesophageal junction cancer
Secondary objective: to construct and validate the efficacy prediction model of chemotherapy combined with immunotherapy for gastric cancer, in order to optimize the scheme decision of advanced gastric cancer treatment
Exploratory purpose: to screen potential molecular markers / dominant flora for predicting the efficacy of immunotherapy in patients with advanced gastric / gastroesophageal junction cancer
- Being tested
- Peripheral blood, tougue coating, saliva, and feces
- Keywords
- Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Chemotherapy combined with immunotherapy, efficacy prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood, tougue coating, saliva, and fecesOther
Peripheral blood, coating, saliva, and feces on the tongue and clinical data of patients with advanced gastric cancer patients who received chemotherapy combined with immunotherapy will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced gastric cancer | Advanced gastric cancer patients receiving chemotherapy combined with immunotherapy Receives: Other: Peripheral blood, tougue coating, saliva, and feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Best Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Measured: 12 months
Overall Survival
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
Measured: 60 months
Secondary outcomes (1)
Progression-free Survival
The period from diagnosis until disease progression or death on study, whichever occurred first.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Mar 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (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 Advanced Gastric CarcinomaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangdong Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642857
- Sponsor's protocol ID
- IRB-2024-175
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We currently have no plans to share individual participant data (IPD) with other researchers.
Publications
Yuan L, Yang L, Zhang S, Xu Z, Qin J, Shi Y, Yu P, Wang Y, Bao Z, Xia Y, Sun J, He W, Chen T, Chen X, Hu C, Zhang Y, Dong C, Zhao P, Wang Y, Jiang N, Lv B, Xue Y, Jiao B, Gao H, Chai K, Li J, Wang H, Wang X, Guan X, Liu X, Zhao G, Zheng Z, Yan J, Yu H, Chen L, Ye Z, You H, Bao Y, Cheng X, Zhao P, Wang L, Zeng W, Tian Y, Chen M, You Y, Yuan G, Ruan H, Gao X, Xu J, Xu H, Du L, Zhang S, Fu H, Cheng X. Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study. EClinicalMedicine. 2023 Feb 6;57:101834. doi: 10.1016/j.eclinm.2023.101834. eCollection 2023 Mar.
PubMed 36825238Li MY, Zhu DJ, Xu W, Lin YJ, Yung KL, Ip AWH. Application of U-Net with Global Convolution Network Module in Computer-Aided Tongue Diagnosis. J Healthc Eng. 2021 Nov 18;2021:5853128. doi: 10.1155/2021/5853128. eCollection 2021.
PubMed 34840700Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/gastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.
- ClinicalTrials.gov ID
- NCT06642857
- Acronym / sponsor ID
- IRB-2024-175
- Keywords
- Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Chemotherapy combined with immunotherapy, efficacy prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xiangdong ChengUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 15 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.
In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers/dominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric/gastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric/gastroesophageal junction cancer.
Detailed description
Main objective: to extract and identify multi omics information tags related to the efficacy of immunotherapy for advanced gastric / gastroesophageal junction cancer
Secondary objective: to construct and validate the efficacy prediction model of chemotherapy combined with immunotherapy for gastric cancer, in order to optimize the scheme decision of advanced gastric cancer treatment
Exploratory purpose: to screen potential molecular markers / dominant flora for predicting the efficacy of immunotherapy in patients with advanced gastric / gastroesophageal junction cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced gastric cancer | – | Other: Peripheral blood, tougue coating, saliva, and fecesAdvanced gastric cancer patients receiving chemotherapy combined with immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Key inclusion criteria (13 listed)
- Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathology and with advanced or metastatic disease that cannot be resected
- HER2 negative
- Not received any anti-tumor treatment before.
- After evaluation, the treatment plan is chemotherapy combined with immunotherapy.
- Aged 18 to 75 years old, gender is not limited.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peripheral blood, tougue coating, saliva, and fecesPeripheral blood, coating, saliva, and feces on the tongue and clinical data of patients with advanced gastric cancer patients who received chemotherapy combined with immunotherapy will be collected. | Other | Patients with advanced gastric cancer |
Primary outcome
Objective Best Tumor Response
Time frame: 12 months
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Overall Survival
Time frame: 60 months
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
1 secondary outcome
Progression-free Survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 36825238Yuan L, Yang L, Zhang S, Xu Z, Qin J, Shi Y, Yu P, Wang Y, Bao Z, Xia Y, Sun J, He W, Chen T, Chen X, Hu C, Zhang Y, Dong C, Zhao P, Wang Y, Jiang N, Lv B, Xue Y, Jiao B, Gao H, Chai K, Li J, Wang H, Wang X, Guan X, Liu X, Zhao G, Zheng Z, Yan J, Yu H, Chen L, Ye Z, You H, Bao Y, Cheng X, Zhao P, Wang L, Zeng W, Tian Y, Chen M, You Y, Yuan G, Ruan H, Gao X, Xu J, Xu H, Du L, Zhang S, Fu H, Cheng X. Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study. EClinicalMedicine. 2023 Feb 6;57:101834. doi: 10.1016/j.eclinm.2023.101834. eCollection 2023 Mar.
- Background: PubMed 34840700Li MY, Zhu DJ, Xu W, Lin YJ, Yung KL, Ip AWH. Application of U-Net with Global Convolution Network Module in Computer-Aided Tongue Diagnosis. J Healthc Eng. 2021 Nov 18;2021:5853128. doi: 10.1155/2021/5853128. eCollection 2021.
- Background: PubMed 36633525Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Individual participant dataSharing planned: Undecided. We currently have no plans to share individual participant data (IPD) with other researchers.
Related trials for Advanced Gastric Carcinoma
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
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
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 Carcinoma and Advanced Gastroesophageal Junction Adenocarcinoma, run by Xiangdong Cheng 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 13 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Cheng Cheng, PhD (+0086-0571-88128041, Chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Best Tumor Response (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?
On the ClinicalTrials.gov record for NCT06642857, 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 15 Oct 2024.