Exploring the Application of 3D Bioprinting for Personalized Treatment in Primary Liver Cancer With Tumor Microenvironment

NCT07437859 | Active Not Recruiting

• 1 other identifier: PLC-3DP-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Liver Cancer

Outcome Measures

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 liver 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 Liver 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.

  From enrollment to end within 2 weeks

Secondary Outcomes (1)

• Response of Gastric Cancer Patients to Adjuvant Chemotherapy

  Up to 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College hospital

Beijing, Beijing Municipality, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

resected tumor tissue from surgery

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD data will available after the study is completed
• Access Criteria: Data can be accessed via e-mail with reasonable requests.

Locations

CN (1)