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RecruitingNCT06451393Updated Jun 11, 2024

Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

An observational study in Gastric Cancer and Chemotherapy Effect, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

From the registry’s dates

  • Started Feb 2013; still recruiting 13 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
20 Years to 90 Years
Sex
All
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Study 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). 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.

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Conditions studied

  • Gastric Cancer
  • Chemotherapy Effect

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Keywords

  • Advanced gastric cancer
  • Neoadjuvant chemotherapy
  • Multimodal
  • Pathological complete response
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In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 500 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Neoadjuvant chemotherapy with radical tumor resection surgery

Interventions

  • DrugNeoadjuvant chemotherapy with radical tumor resection surgery

    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).

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What researchers measure

Primary outcomes

  1. Pathological Complete Response

    Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.

    Time frame: Assessed within 30 days after radical resection surgery.

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Study locations

1 of 1 sites recruiting
  • The Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
    Recruiting
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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06451393
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Feb 1, 2013
Primary completion
Sep 30, 2022
Completion
Dec 30, 2026 (estimated)
Last update
Jun 11, 2024

Study contacts

Yonghe Chen, MD
Contact
chenyhe@mail2.sysu.edu.cn
+86 135 6038 6150
Junsheng Peng, MD
Contact
pengjsh@mail.sysu.edu.cn
+86 13802963578
Junsheng Peng, MD
principal investigator · Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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