- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437859
Exploring the Application of 3D Bioprinting for Personalized Treatment in Primary Liver Cancer With Tumor Microenvironment
Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Primary Liver Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment and Explore The Tumor Microenvironment to Resistance for Liver Cancer
Primary liver cancer, predominantly hepatocellular carcinoma (HCC), represents a major global health burden, with high incidence and mortality rates. It ranks among the leading causes of cancer-related deaths worldwide, due largely to late diagnosis and limited therapeutic efficacy. Conventional treatment selection often relies on generalized guidelines rather than individualized response prediction, leading to suboptimal outcomes.
The necessity of utilizing in vitro 3D bioprinting of patient-derived tumor tissue for drug sensitivity testing lies in its ability to closely mimic the in vivo tumor microenvironment. This technology allows for the evaluation of therapeutic agents against a biologically relevant model before clinical administration, enabling personalized treatment strategies. Such an approach holds promise for improving drug response prediction, reducing ineffective treatments, and ultimately enhancing patient survival and quality of life.
Therefore, integrating 3D-bioprinted tumor models into pharmacotyping represents a significant advance toward precision oncology in primary liver cancer management.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of other malignancies or serious medical conditions
- Inability to provide independent informed consent
Description
Inclusion Criteria:
- 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:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
Time Frame: From enrollment to end within 2 weeks
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From enrollment to end within 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response of Gastric Cancer Patients to Adjuvant Chemotherapy
Time Frame: Up to 2 years
|
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.
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Up to 2 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLC-3DP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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