Gastric CancerNCT06451393
Predicting Gastric Cancer Response to Chemo With Multimodal AI Model
An observational study of Gastric Cancer and Chemotherapy Effect, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect
- What is being tested?
- Neoadjuvant chemotherapy with radical tumor resection surgery
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2013to 30 Dec 2026
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;
Who may be able to join
- patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
- patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
- Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1
Who cannot join
- Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
- patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
- patients with insufficient data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiangen Lu, Master, +86 20 3837 9764, zslyllb@mail.sysu.edu.cn
About this study
Official title: A Radio-Pathomic Multimodal Machine Learning Model for Predicting Pathological Complete Response to Neoadjuvant Chemotherapy in Advanced Gastric Cancer: A Retrospective Observational Study
This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Being tested
- Neoadjuvant chemotherapy with radical tumor resection surgery
- Keywords
- Advanced gastric cancer, Neoadjuvant chemotherapy, Multimodal, Pathological complete response
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy with radical tumor resection surgeryDrug
All patients were pathologically diagnosed as advanced gastric cancer, all receive neoadjuvant chemotherapy, after the completion of neoadjuvant chemotherapy, all patients receive radical tumor resection surgery (partial gastrectomy or total gastrectomy, as proper).
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy with radical tumor resection surgery | (i) Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection; (ii) patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling; (iii) patients with insufficient data. Receives: Drug: Neoadjuvant chemotherapy with radical tumor resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.
Measured: Assessed within 30 days after radical resection surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Feb 2013
- Primary completion30 Sep 2022
- Study completion30 Dec 2026 (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 Sixth Affiliated Hospital, Sun Yat-sen 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junsheng Peng, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451393
- Sponsor's protocol ID
- E2021088
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from Dr. Junsheng Peng (E-mail: pengjsh@mail.sysu.edu.cn) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radio-Pathomic Multimodal Machine Learning Model for Predicting Pathological Complete Response to Neoadjuvant Chemotherapy in Advanced Gastric Cancer: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06451393
- Acronym / sponsor ID
- E2021088
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Keywords
- Advanced gastric cancer, Neoadjuvant chemotherapy, Multimodal, Pathological complete response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jun 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.
This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy with radical tumor resection surgery | – | Drug: Neoadjuvant chemotherapy with radical tumor resection surgery(i) Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection; (ii) patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling; (iii) patients with insufficient data. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;
Key inclusion criteria (3 listed)
- patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
- patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
- Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1
Key exclusion criteria (3 listed)
- Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
- patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
- patients with insufficient data.
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 |
|---|---|---|
| Neoadjuvant chemotherapy with radical tumor resection surgeryAll patients were pathologically diagnosed as advanced gastric cancer, all receive neoadjuvant chemotherapy, after the completion of neoadjuvant chemotherapy, all patients receive radical tumor resection surgery (partial gastrectomy or total gastrectomy, as proper). | Drug | Neoadjuvant chemotherapy with radical tumor resection surgery |
Primary outcome
Pathological Complete Response
Time frame: Assessed within 30 days after radical resection surgery.
Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.
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 11 Jun 2024.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from Dr. Junsheng Peng (E-mail: pengjsh@mail.sysu.edu.cn) upon reasonable request.
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.
Junsheng Peng, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 Gastric Cancer and Chemotherapy Effect, run by Sixth Affiliated Hospital, Sun Yat-sen 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Jun 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?
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 Yonghe Chen, MD (+86 135 6038 6150, chenyhe@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: Assessed within 30 days after radical resection surgery.). 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 11 Jun 2024.