Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:10 AM
Study NCT ID:
NCT07437859
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Application of 3D Bioprinting for Personalized Treatment in Primary Liver Cancer With Tumor Microenvironment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'resected tumor tissue from surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients', 'timeFrame': 'From enrollment to end within 2 weeks', 'description': "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.\n2. 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."}], 'secondaryOutcomes': [{'measure': 'Response of Gastric Cancer Patients to Adjuvant Chemotherapy', 'timeFrame': 'Up to 2 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Liver Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nTherefore, integrating 3D-bioprinted tumor models into pharmacotyping represents a significant advance toward precision oncology in primary liver cancer management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* More than 18 years old\n* Patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* History of other malignancies or serious medical conditions\n* Inability to provide independent informed consent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT07437859', 'briefTitle': 'Exploring the Application of 3D Bioprinting for Personalized Treatment in Primary Liver Cancer With Tumor Microenvironment', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PLC-3DP-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD data will available after the study is completed', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.', 'accessCriteria': 'Data can be accessed via e-mail with reasonable requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}