Locally Advanced Gastric CarcinomaNCT06396143
Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
An observational study of Locally Advanced Gastric Carcinoma, run by Zhejiang University at 4 sites in China.
Trial summary
In this study, investigators utilize a radiopathomics integrated Artificial Intelligence (AI) supportive system to predict tumor response to neoadjuvant chemoradiotherapy (nCRT) before its administration for patients with locally advanced gastric cancer (LAGC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Carcinoma
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2024to 1 Dec 2025
- How long will I take part?
- 2 Years
- 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: The population in the study is LAGC patients who plan to receive standard neoadjuvant concurrent chemotherapy or combination immunotherapy and targeted therapy, but the tumor pathological response is unknown.
Who may be able to join
- Pathological diagnosis of gastric adenocarcinoma
- Gastric cancer CT evaluation is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis.
- Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with anti-PD-L1 treatment regimen.
- D2 gastric cancer radical surgery after neoadjuvant therapy
- Digital images of enhanced CT images and HE stained gastroscopy biopsy sections before neoadjuvant therapy are available.
- Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers.
Who cannot join
- Has a history of other tumors.
- Insufficient imaging quality of CT or biopsy slides, unable to obtain features.
- Unable to extract molecular information related to research from organizational samples.
- Interruption of neoadjuvant therapy course for any reason.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Gastrointestinal Department of First Affiliated Hospital of Zhejiang University
Hanzhou, Zhejiang, 310000
Jian Chen, +8613957102733, zrchenjian@zju.edu.cn
- Recruiting
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hanzhou, Zhejiang, 310000
Jian Chen, +86-13957102733, zrchenjian@zju.edu.cn
- Recruiting
Gastrointestinal Department of Zhejiang Cancer Hospital
Hanzhou, Zhejiang, 310000
Jian Chen, +8613957102733, zrchenjian@zju.edu.cn
- Recruiting
Shaoxing Shangyu People's Hospital
Shaoxing, Zhejiang, 312000
Jian Chen, +8613957102733, zrchenjian@zju.edu.cn
About this study
In this study, investigators utilize a radiopathomics integrated Artificial Intelligence (AI) supportive system to predict tumor response to neoadjuvant chemoradiotherapy (nCRT) before its administration for patients with locally advanced gastric cancer (LAGC). By the system, the postoperative tumor regression grade (TRG) of the participants will be identified based on the radiopathomics features extracted from the pre-nCRT Enhanced CT and biopsy images. The ability to predict TRG will be validated in this multicenter, prospective clinical study.
Read the detailed description
This is a multicenter, prospective, observational clinical study for validation of a radiopathomics artificial intelligence (AI) system. Patients who have been diagnosed with gastric adenocarcinoma by pathology and defined as clinical stage II-IVa without distant metastasis by enhanced CT scan will be enrolled from the Second Affiliated Hospital of Zhejiang University, the First Affiliated Hospital of Zhejiang University, Shangyu People's Hospital of Shaoxing City and Zhejiang Cancer Institute \& Hospital. All participants should adhere to a highly standardized treatment protocol, which involves receiving either 2-4 courses of standard neoadjuvant chemotherapy based on 5-FU + platinum, or 2-4 courses of neoadjuvant chemotherapy based on 5-FU + platinum combined with trastuzumab, or 2-4 courses of neoadjuvant chemotherapy based on 5-FU + platinum combined with anti-PD-L1 therapy. Following the neoadjuvant treatment protocol, participants will undergo a D2 radical gastrectomy for gastric cancer. The enhanced CT and biopsy examination should be completed before the nCRT and the images will be subjected to the manual delineation of the tumor regions of interest (ROI) by experienced radiologists and pathologists. Subsequently, the enhanced CT and biopsy images outlined will be used in the radiological pathology AI system to generate predicted responses (predicted postoperative TRG grading) for individual patients, while actual responses (confirmed postoperative TRG grading) will be diagnosed in surgical resection specimens. Through comparisons of the predicted responses and true pathologic responses, investigators calculate the prediction accuracy, specificity, sensitivity as well as the Area Under Curve (AUC) of Receiver Operating Characteristic (ROC) curves. The aim of this study is to verify the high accuracy and robustness of the radiological pathology AI system in predicting postoperative TRG grading in individuals before nCRT, which will promote further precise treatment of locally advanced cancer patients.
- Conditions
- Locally Advanced Gastric Carcinoma
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, Immunotherapy, Targeted therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy group | a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum based neoadjuvant chemotherapy regimen. D2 gastric cancer radical surgery will be performed after the neoadjuvant treatment regimen； e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. | |
| Neoadjuvant chemotherapy combined with PD1 or PDL1 group | a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for a 2-4 course treatment regimen based on 5-FU+platinum neoadjuvant chemotherapy combined with anti PD-L1 therapy; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. | |
| Neoadjuvant chemotherapy combined with trastuzumab group | a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathomics artificial intelligence model
Calculate the area under the receiver operating characteristic (ROC) curve (AUC) of the artificial intelligence model for radiomics to predict the postoperative pathological TRG grading index in LAGC patients treated with nCRT.
Measured: baseline
Secondary outcomes (2)
The specificity of the radiopathomics artificial intelligence model
the specificity of artificial intelligence models for radiomics in predicting postoperative TRG grading in LAGC patients treated with nCRT.
Measured: baseline
The sensitivity of the radiopathomics artificial intelligence model
The sensitivity of artificial intelligence models for radiomics in predicting postoperative TRG grading in LAGC patients treated with nCRT.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (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 Locally 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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Chen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396143
- Sponsor's protocol ID
- WKJ-ZJ-2310
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng L, Liu Z, Li C, Li Z, Lou X, Shao L, Wang Y, Huang Y, Chen H, Pang X, Liu S, He F, Zheng J, Meng X, Xie P, Yang G, Ding Y, Wei M, Yun J, Hung MC, Zhou W, Wahl DR, Lan P, Tian J, Wan X. Development and validation of a radiopathomics model to predict pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a multicentre observational study. Lancet Digit Health. 2022 Jan;4(1):e8-e17. doi: 10.1016/S2589-7500(21)00215-6.
PubMed 34952679
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
- ClinicalTrials.gov ID
- NCT06396143
- Acronym / sponsor ID
- WKJ-ZJ-2310
- Conditions
- Locally Advanced Gastric Carcinoma
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, Immunotherapy, Targeted therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 2 May 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 study, investigators utilize a radiopathomics integrated Artificial Intelligence (AI) supportive system to predict tumor response to neoadjuvant chemoradiotherapy (nCRT) before its administration for patients with locally advanced gastric cancer (LAGC). By the system, the postoperative tumor regression grade (TRG) of the participants will be identified based on the radiopathomics features extracted from the pre-nCRT Enhanced CT and biopsy images. The ability to predict TRG will be validated in this multicenter, prospective clinical study.
Detailed description
This is a multicenter, prospective, observational clinical study for validation of a radiopathomics artificial intelligence (AI) system. Patients who have been diagnosed with gastric adenocarcinoma by pathology and defined as clinical stage II-IVa without distant metastasis by enhanced CT scan will be enrolled from the Second Affiliated Hospital of Zhejiang University, the First Affiliated Hospital of Zhejiang University, Shangyu People's Hospital of Shaoxing City and Zhejiang Cancer Institute \& Hospital. All participants should adhere to a highly standardized treatment protocol, which involves receiving either 2-4 courses of standard neoadjuvant chemotherapy based on 5-FU + platinum, or 2-4 courses of neoadjuvant chemotherapy based on 5-FU + platinum combined with trastuzumab, or 2-4 courses of neoadjuvant chemotherapy based on 5-FU + platinum combined with anti-PD-L1 therapy. Following the neoadjuvant treatment protocol, participants will undergo a D2 radical gastrectomy for gastric cancer. The enhanced CT and biopsy examination should be completed before the nCRT and the images will be subjected to the manual delineation of the tumor regions of interest (ROI) by experienced radiologists and pathologists. Subsequently, the enhanced CT and biopsy images outlined will be used in the radiological pathology AI system to generate predicted responses (predicted postoperative TRG grading) for individual patients, while actual responses (confirmed postoperative TRG grading) will be diagnosed in surgical resection specimens. Through comparisons of the predicted responses and true pathologic responses, investigators calculate the prediction accuracy, specificity, sensitivity as well as the Area Under Curve (AUC) of Receiver Operating Characteristic (ROC) curves. The aim of this study is to verify the high accuracy and robustness of the radiological pathology AI system in predicting postoperative TRG grading in individuals before nCRT, which will promote further precise treatment of locally advanced cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy group | – | –a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum based neoadjuvant chemotherapy regimen. D2 gastric cancer radical surgery will be performed after the neoadjuvant treatment regimen； e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. |
| Neoadjuvant chemotherapy combined with PD1 or PDL1 group | – | –a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for a 2-4 course treatment regimen based on 5-FU+platinum neoadjuvant chemotherapy combined with anti PD-L1 therapy; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. |
| Neoadjuvant chemotherapy combined with trastuzumab group | – | –a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population in the study is LAGC patients who plan to receive standard neoadjuvant concurrent chemotherapy or combination immunotherapy and targeted therapy, but the tumor pathological response is unknown.
Key inclusion criteria (6 listed)
- Pathological diagnosis of gastric adenocarcinoma
- Gastric cancer CT evaluation is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis.
- Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with anti-PD-L1 treatment regimen.
- D2 gastric cancer radical surgery after neoadjuvant therapy
- Digital images of enhanced CT images and HE stained gastroscopy biopsy sections before neoadjuvant therapy are available.
Key exclusion criteria (4 listed)
- Has a history of other tumors.
- Insufficient imaging quality of CT or biopsy slides, unable to obtain features.
- Unable to extract molecular information related to research from organizational samples.
- Interruption of neoadjuvant therapy course for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathomics artificial intelligence model
Time frame: baseline
Calculate the area under the receiver operating characteristic (ROC) curve (AUC) of the artificial intelligence model for radiomics to predict the postoperative pathological TRG grading index in LAGC patients treated with nCRT.
2 secondary outcomes
The specificity of the radiopathomics artificial intelligence model
Time frame: baseline
The sensitivity of the radiopathomics artificial intelligence model
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 34952679Feng L, Liu Z, Li C, Li Z, Lou X, Shao L, Wang Y, Huang Y, Chen H, Pang X, Liu S, He F, Zheng J, Meng X, Xie P, Yang G, Ding Y, Wei M, Yun J, Hung MC, Zhou W, Wahl DR, Lan P, Tian J, Wan X. Development and validation of a radiopathomics model to predict pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a multicentre observational study. Lancet Digit Health. 2022 Jan;4(1):e8-e17. doi: 10.1016/S2589-7500(21)00215-6.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Gastric Carcinoma, run by Zhejiang University at 4 sites 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 4 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Jian Chen (+86-13957102733, zrchenjian@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathomics artificial intelligence model (time frame: baseline). 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 NCT06396143, 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 2 May 2024.