Gastric CancerNCT04913896
CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy
An observational study of Gastric Cancer and Magnetic Resonance Imaging, run by The First Hospital of Jilin University.
Trial summary
This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Magnetic Resonance Imaging, Tomography, X-Ray Computed
- What is being tested?
- PD-1 inhibitor
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2023
- How long will I take part?
- 3 Months
- 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: Patients with endoscopically biopsy-proven gastric cancer will receive preoperative neoadjuvant immunotherapy and/or chemotherapy.
Who may be able to join
- Age 18 Years to 80 Years
- Consecutive patients with preoperative pathologically confirmed AGC by endoscopy and preoperative imaging data (CT/MRI) were included.
- Clinical staging Ⅱ-Ⅲ according to the UICC/AJCC 8th guideline for gastric cancer without distant metastasis.
- Suitable for pre-operative chemotherapy, immunotherapy and surgical resection
- No contraindications for CT/MRI examination.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- The patients participate in this study with informed consent.
Who cannot join
- Patients with a history of previous chemotherapy or immunotherapy.
- The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
- The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
- The patients refuse to participate in the project.
- Pregnancy, lactation or inadequate contraception
- Pacemaker or implanted defibrillator
- Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
- Other situations considered by investigators, which not meet the inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy
This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. This study will help the surgeons to better formulate treatment regimens for gastric cancer in the clinical practice.
Read the detailed description
With the gradual development of neoadjuvant immunotherapy and/or chemotherapy in the clinic, the pCR has become more and more accessible in the AGC. Preoperative accurate prediction of pCR is of great clinical significance. The contrast-enhanced CT and 3.0T MRI were carried out in patients within 1 week prior to commencing neoadjuvant treatment, as well as 1 week within surgery after the completion of neoadjuvant treatment, respectively. Based on the information extracted from the CT/MRI, the clinical completed response (cCR) and the clinical T staging were compared with pCR, pathologic T staging. The pathologic results were considered as the golden standard. With the ROC curve analysis, the diagnosis coincidence rate, sensitivity and specificity were assessed. The AI prediction model would be constructed and trained. The depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric cancer treated with systematic therapy. The abdominal contrast-enhanced CT will focus on parameters: Local T Staging, nodal status, diameter, according to RECIST 1.1. MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will focus on parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local T Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.
- Conditions
- Gastric Cancer, Magnetic Resonance Imaging, Tomography, X-Ray Computed, Neoadjuvant Immunotherapy, Neoadjuvant Chemotherapy
- Being tested
- PD-1 inhibitor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
Also called Oxaliplatin, Tiggio
SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Patients with AGC who underwent neoadjuvant immunotherapy and/or chemotherapy would recieve MRI and CT examination before and after 3 cycles treatment. Receives: Drug: PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).
Measured: up to 2 year
Secondary outcomes (3)
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging
To evaluate the T staging of gastric cancer treated with neoadjuvant treatment through CT and MRI.
Measured: up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)
Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.
Measured: up to 2 year
Prediction model based on CT and MRI of response in AGC
To construct a model, a depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric/rectal cancer treated with systematic therapy.
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- quan wang, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913896
- Sponsor's protocol ID
- STARS-GC03
- Status last verified
- Apr 2021
- First submitted
- 10 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no share
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy
- ClinicalTrials.gov ID
- NCT04913896
- Acronym / sponsor ID
- STARS-GC03
- Conditions
- Gastric Cancer, Magnetic Resonance Imaging, Tomography, X-Ray Computed, Neoadjuvant Immunotherapy, Neoadjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 4 Jun 2021 (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.
This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. This study will help the surgeons to better formulate treatment regimens for gastric cancer in the clinical practice.
Detailed description
With the gradual development of neoadjuvant immunotherapy and/or chemotherapy in the clinic, the pCR has become more and more accessible in the AGC. Preoperative accurate prediction of pCR is of great clinical significance. The contrast-enhanced CT and 3.0T MRI were carried out in patients within 1 week prior to commencing neoadjuvant treatment, as well as 1 week within surgery after the completion of neoadjuvant treatment, respectively. Based on the information extracted from the CT/MRI, the clinical completed response (cCR) and the clinical T staging were compared with pCR, pathologic T staging. The pathologic results were considered as the golden standard. With the ROC curve analysis, the diagnosis coincidence rate, sensitivity and specificity were assessed. The AI prediction model would be constructed and trained. The depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric cancer treated with systematic therapy. The abdominal contrast-enhanced CT will focus on parameters: Local T Staging, nodal status, diameter, according to RECIST 1.1. MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will focus on parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local T Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | Drug: PD-1 inhibitorPatients with AGC who underwent neoadjuvant immunotherapy and/or chemotherapy would recieve MRI and CT examination before and after 3 cycles treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with endoscopically biopsy-proven gastric cancer will receive preoperative neoadjuvant immunotherapy and/or chemotherapy.
Key inclusion criteria (7 listed)
- Age 18 Years to 80 Years
- Consecutive patients with preoperative pathologically confirmed AGC by endoscopy and preoperative imaging data (CT/MRI) were included.
- Clinical staging Ⅱ-Ⅲ according to the UICC/AJCC 8th guideline for gastric cancer without distant metastasis.
- Suitable for pre-operative chemotherapy, immunotherapy and surgical resection
- No contraindications for CT/MRI examination.
Key exclusion criteria (8 listed)
- Patients with a history of previous chemotherapy or immunotherapy.
- The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
- The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
- The patients refuse to participate in the project.
- Pregnancy, lactation or inadequate contraception
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 |
|---|---|---|
| PD-1 inhibitorAlso: Oxaliplatin, TiggioSOX regimen for 3 cycles and/or PD-1 inhibitor before surgery | Drug | Single Group Assignment |
Primary outcome
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery
Time frame: up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).
3 secondary outcomes
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging
Time frame: up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)
Time frame: up to 2 year
Prediction model based on CT and MRI of response in AGC
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No. no share
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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.
quan wang, MD principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Magnetic Resonance Imaging, run by The First Hospital of Jilin 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 8 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 4 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact quan wang, MD (15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery (time frame: up to 2 year). 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 4 Jun 2021.