Primary Liver CancerNCT07437859
Exploring the Application of 3D Bioprinting for Personalized Treatment in Primary Liver Cancer With Tumor Microenvironment
An observational study of Primary Liver Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Liver Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
- Conditions
- Primary Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
- 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.
- 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.
Measured: From enrollment to end within 2 weeks
Secondary 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437859
- Sponsor's protocol ID
- PLC-3DP-001
- Status last verified
- Oct 2025
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07437859
- Acronym / sponsor ID
- PLC-3DP-001
- Conditions
- Primary Liver Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
Time frame: From enrollment to end within 2 weeks
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.
1 secondary outcome
Response of Gastric Cancer Patients to Adjuvant Chemotherapy
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
Related trials for Primary Liver Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
Liver Ablation, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients (time frame: From enrollment to end within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.