Prediction of Drug Response in Gastric Cancer Based on 3D Bioprinting
ConditionSTOMACH NEOPLASM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
The therapeutic regimens for adjuvant and neoadjuvant chemotherapy in gastric cancer (GC) predominantly hinge on clinical experience. Consequently, there is an imperative need for preclinical models to facilitate the guidance of individualized medicine. The investigators plan to establish three-dimensional (3D) bioprinted GC models derived from surgically resected tumor tissues of GC patients. These in vitro 3D models will be subjected to treatment with the identical chemotherapy drugs administered to the corresponding patients from whom the models are sourced. The sensitivity of the chemotherapy drugs will be assayed within the in vitro models, and the actual response to chemotherapy in patients will be meticulously evaluated. This observational study aims to substantiate the potential utility of 3D bioprinted tumor models in prognosticating the response to chemotherapy in GC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
More than 18 years old
Patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively.
Patients who have undergone preoperative imaging examinations, including plain and contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as gastric MRI for tumor staging, and who are planned for preoperative (neo)adjuvant therapy after multidisciplinary team (MDT) discussion; patients with advanced gastric cancer who are confirmed by postoperative pathology to require (neo)adjuvant therapy.
The patient or their family members are able to comprehend the research protocol and are willing to participate in this study, providing written informed consent.
Disqualifiers
History of other malignancies or serious medical conditions
Inability to provide independent informed consent
Trial population
Individuals with a clinical and pathological diagnosis of gastric cancer are deemed eligible for this study. Clinical physicians will meticulously record the medical histories, restricting inclusion to patients aged 18 years and above. Exclusion criteria encompass individuals with concomitant malignancies or severe comorbidities. Patients incapable of providing autonomous informed consent are ineligible for participation. All participants will undergo adjuvant or neoadjuvant chemotherapy, followed by surgical resection, as part of the treatment protocol for localized gastric cancer.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
surgical resection
Procedure/SurgerySurgical resection will be performed for locoregional lesions .
Adjuvant chemotherapy
Other interventionRegimens of adjuvant chemotherapy are directed by clinical guidance and experience.
neoadjuvant therapy
Other interventionRegimens of neoadjuvant chemotherapy are directed by clinicalguidance and experience
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group A2 interventions
Group B: Group B3 interventions
Group C: Group C1 intervention
Trial outcomes
Primary outcomes
1
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
1. Response of 3D tumor models to chemotherapy drugs identical to those administered to corresponding patients: Researchers will establish and culture 3D printed gastric cancer models and treat them with the same chemotherapy drugs used for the corresponding patients. Following treatment, the viability of the 3D tumor models will be observed, and the IC50 of each drug will be calculated. The correlation between the sensitivity of the 3D models and the patients' responses will be analyzed. 2. Response of Gastric Cancer Patients to Neoadjuvant Chemotherapy: For patients who undergo neoadjuvant chemotherapy prior to surgery, the response to such treatment will be assessed based on clinical imaging results, the Mandard-TRG criteria, and the RECIST score.
Time frame
From enrollment to end within 2 weeksSecondary outcomes
1
Response of Gastric Cancer Patients to Adjuvant Chemotherapy
The response to adjuvant chemotherapy will be assessed based on disease-free survival (DFS) or Overall Survival (OS). Regular follow-ups will be conducted. DFS is defined as the interval between the date of surgery and the date of the last follow-up or the date of recurrence/progression.Overall survival (OS) is delineated as the temporal span from the date of surgery to the date of death or the date of the last follow-up, whichever occurs first.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov