Hepatocellular Carcinoma ResectablePhase 2NCT07363356
Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer
A Phase 2 study testing Organoid Drug Sensitivity Testing-Guided Therapy in people with Hepatocellular Carcinoma Resectable, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma Resectable
- What is being tested?
- Organoid Drug Sensitivity Testing-Guided Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 30 Nov 2028
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 70 years.
- Diagnosed with primary liver cancer according to the diagnostic criteria of the primary liver cancer (e.g., Guidelines for Diagnosis and Treatment of Primary Liver Cancer), with post-operative pathological confirmation of hepatocellular carcinoma (HCC). Patients must have at least one of the following high-risk pathological features: tumor diameter >5 cm, more than 3 tumors, presence of microvascular invasion, presence of minor macrovascular invasion, or poor pathological differentiation (Grade 3/4).
- The subject or their legal guardian understands and voluntarily signs the informed consent form, and is willing and able to complete the scheduled visits, treatment plan, and laboratory tests as required by the protocol.
- Life expectancy of more than 6 months.
- No radiotherapy within 12 weeks prior to the first dose of study drug.
- Liver function classified as Child-Pugh Class A or Class B with a score of 7.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function, defined as laboratory values meeting the following criteria within 7 days prior to randomization (without the support of blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to obtaining the laboratory tests):
- 8.1. Hematological:
- 8.1. 2. Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L
- 8.1. 3. Platelet count (PLT) ≥75 × 10⁹/L
- 8.1. 4. Hemoglobin (HGB) ≥9.0 g/dL
- 8.2. Hepatic:
- 8.2.1. Total Bilirubin (TBIL) ≤3 × Upper Limit of Normal (ULN)
- 8.2.2. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤5 × ULN
- 8.2.3. Serum Albumin ≥28 g/L
- 8.3. Renal:
- 8.3.1. Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula)
- 8.3.2. Urinalysis shows urine protein < 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification <1 g.
- 8.4. Coagulation:
- 8.4.1. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
- For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of <1% per year) during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy agents).
Who cannot join
- Uncorrectable coagulopathy or significant bleeding tendency.
- Evidence of any concurrent malignant disease.
- Diagnosed with another malignancy within 3 years prior to the first dose, except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone curative resection.
- Requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.
- Presence of hepatic encephalopathy or refractory pleural effusion/ascites requiring therapeutic intervention.
- Received other anti-tumor or systemic therapies within 2 weeks prior to enrollment, including:
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- 6.1. Chinese herbal medicines with clear anti-tumor properties.
- 6.2. Chinese herbal medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
- History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:
- 7.1. autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement) is not considered a form of systemic treatment.
- 7.2. Systemic corticosteroid therapy (excluding topical, nasal, inhaled, or other non-systemic routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted.
- Severe hepatic or renal insufficiency.
- Presence of any severe or uncontrolled systemic disease, including but not limited to:
- 9.1. Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation).
- 9.2. Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).
- 9.3. Myocardial infarction within 6 months prior to randomization.
- 9.4. History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.
- 9.5. Poorly controlled hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg).
- 9.6. History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.
- 9.7. Active tuberculosis.
- 9.8. Active or uncontrolled infection requiring systemic therapy.
- 9.9. Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- 9.10. Decompensated liver disease, acute or chronic active hepatitis.
- 9.11. Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.
- 9.12. Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L).
- 9.13. Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein >1.0 g.
- 9.14. Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium, or calcium >12 mg/dL, or corrected serum calcium > ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.
- 9.15. Non-healing wound(s) or fracture(s).
- 9.16. Psychiatric disorder that compromises the ability to comply with the treatment protocol.
- Female subjects who are breastfeeding or pregnant.
- Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.
- Known allergy to any of the study drug(s) used in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Third Affiliated Hospital of Naval Medical University, Shanghai, Shanghai 200433/201805
Shanghai
Kui Wang, +86 13636330827, wangkuiykl@163.com
About this study
Official title: Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer: A Prospective, Non-Randomized，Open-Label, Phase II Clinical Trial
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver resection. A total of 56 eligible patients will be enrolled. Tumor tissues obtained during surgery will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib + Toripalimab, Sintilimab, and FOLFOX) to identify the most effective treatment for each patient. Patients for whom organoid testing fails or results are unavailable within the specified timeframe will receive standard Lenvatinib treatment. The primary endpoint is Recurrence-Free Survival (RFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel strategy for personalized adjuvant therapy in HCC to improve patient outcomes.
Read the detailed description
- Study Design: This is a single-center, prospective, non-randomized, open-label, phase II clinical trial conducted at the Third Affiliated Hospital of Naval Medical University. The study aims to validate the clinical utility of tumor organoid drug sensitivity testing in personalizing adjuvant therapy for hepatocellular carcinoma (HCC) after curative liver resection.
- Study Population: The study will enroll 56 adult patients (aged 18-70) with primary HCC who have undergone curative liver resection and are at high risk of recurrence (e.g., tumor diameter >5 cm, multiple tumors, microvascular invasion, poor differentiation). Participants must have adequate organ function, an ECOG performance status of 0-1, and a life expectancy of >6 months.
- Interventions: Organoid Drug Sensitivity Testing (ODST) Group: Fresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy. Control Group (Empirical Treatment): Patients for whom organoid construction fails, or valid drug sensitivity results are not available within 1 month, receive standard Lenvatinib treatment.
- Study Endpoints: Primary Endpoint: Recurrence-Free Survival (RFS), defined as the time from treatment initiation to tumor recurrence. Secondary Endpoints: Overall Survival (OS) Safety and tolerability, assessed by the incidence and severity of adverse events (AEs, SAEs) according to NCI CTCAE v5.0.
- Follow-up: Patients will be followed regularly with imaging (every 42±3 days initially, then every 3 months for the first year, and every 6 months thereafter) and laboratory assessments to monitor for recurrence and adverse events until death, withdrawal of consent, or study termination.
- Statistical Analysis:
Sample size was calculated based on an assumed improvement in median RFS from 11.0 months (empirical group) to 33.0 months (ODST-guided group) (α=0.05, power=80%, 1:1 allocation, 10% dropout rate). Statistical analyses will be performed using SAS, with descriptive statistics for safety and efficacy analyses.
- Conditions
- Hepatocellular Carcinoma Resectable
- Being tested
- Organoid Drug Sensitivity Testing-Guided Therapy
- Keywords
- organoid;, drug-sensitive test;, adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid Drug Sensitivity Testing-Guided TherapyDrug
Fresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Organoid Drug Sensitivity Testing-Guided Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survial(RFS)
Measured: Up to approximately 5 years
1year-RFS rate
Measured: 1-years
3years-RFS Rate
Measured: 3-years
5years-RFS Rate
Measured: 5-years
Secondary outcomes (5)
Overall Survival（OS）
Measured: Up to approximately 5 years
Incidence of Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Up to approximately 4 years
1year-OS rate
Measured: 1-year
3years-OS Rate
Measured: 3-years
5years-OS Rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma ResectableStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Feng Shen, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363356
- Sponsor's protocol ID
- EHBHKY2025-H030-P001
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer: A Prospective, Non-Randomized，Open-Label, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07363356
- Acronym / sponsor ID
- EHBHKY2025-H030-P001
- Conditions
- Hepatocellular Carcinoma Resectable
- Keywords
- organoid;, drug-sensitive test;, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 Jan 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.
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver resection. A total of 56 eligible patients will be enrolled. Tumor tissues obtained during surgery will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib + Toripalimab, Sintilimab, and FOLFOX) to identify the most effective treatment for each patient. Patients for whom organoid testing fails or results are unavailable within the specified timeframe will receive standard Lenvatinib treatment. The primary endpoint is Recurrence-Free Survival (RFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel strategy for personalized adjuvant therapy in HCC to improve patient outcomes.
Detailed description
- Study Design: This is a single-center, prospective, non-randomized, open-label, phase II clinical trial conducted at the Third Affiliated Hospital of Naval Medical University. The study aims to validate the clinical utility of tumor organoid drug sensitivity testing in personalizing adjuvant therapy for hepatocellular carcinoma (HCC) after curative liver resection.
- Study Population: The study will enroll 56 adult patients (aged 18-70) with primary HCC who have undergone curative liver resection and are at high risk of recurrence (e.g., tumor diameter >5 cm, multiple tumors, microvascular invasion, poor differentiation). Participants must have adequate organ function, an ECOG performance status of 0-1, and a life expectancy of >6 months.
- Interventions: Organoid Drug Sensitivity Testing (ODST) Group: Fresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy. Control Group (Empirical Treatment): Patients for whom organoid construction fails, or valid drug sensitivity results are not available within 1 month, receive standard Lenvatinib treatment.
- Study Endpoints: Primary Endpoint: Recurrence-Free Survival (RFS), defined as the time from treatment initiation to tumor recurrence. Secondary Endpoints: Overall Survival (OS) Safety and tolerability, assessed by the incidence and severity of adverse events (AEs, SAEs) according to NCI CTCAE v5.0.
- Follow-up: Patients will be followed regularly with imaging (every 42±3 days initially, then every 3 months for the first year, and every 6 months thereafter) and laboratory assessments to monitor for recurrence and adverse events until death, withdrawal of consent, or study termination.
- Statistical Analysis:
Sample size was calculated based on an assumed improvement in median RFS from 11.0 months (empirical group) to 33.0 months (ODST-guided group) (α=0.05, power=80%, 1:1 allocation, 10% dropout rate). Statistical analyses will be performed using SAS, with descriptive statistics for safety and efficacy analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Organoid Drug Sensitivity Testing-Guided Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female, aged 18 to 70 years.
- Diagnosed with primary liver cancer according to the diagnostic criteria of the primary liver cancer (e.g., Guidelines for Diagnosis and Treatment of Primary Liver Cancer), with post-operative pathological confirmation of hepatocellular carcinoma (HCC). Patients must have at least one of the following high-risk pathological features: tumor diameter >5 cm, more than 3 tumors, presence of microvascular invasion, presence of minor macrovascular invasion, or poor pathological differentiation (Grade 3/4).
- The subject or their legal guardian understands and voluntarily signs the informed consent form, and is willing and able to complete the scheduled visits, treatment plan, and laboratory tests as required by the protocol.
- Life expectancy of more than 6 months.
- No radiotherapy within 12 weeks prior to the first dose of study drug.
Key exclusion criteria (32 listed)
- Uncorrectable coagulopathy or significant bleeding tendency.
- Evidence of any concurrent malignant disease.
- Diagnosed with another malignancy within 3 years prior to the first dose, except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone curative resection.
- Requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.
- Presence of hepatic encephalopathy or refractory pleural effusion/ascites requiring therapeutic intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid Drug Sensitivity Testing-Guided TherapyFresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy. | Drug | Arm 1 |
Primary outcome
Recurrence-free Survial(RFS)
Time frame: Up to approximately 5 years
1year-RFS rate
Time frame: 1-years
3years-RFS Rate
Time frame: 3-years
5years-RFS Rate
Time frame: 5-years
5 secondary outcomes
Overall Survival（OS）
Time frame: Up to approximately 5 years
Incidence of Adverse Events (AEs)
Time frame: Up to approximately 4 years
1year-OS rate
Time frame: 1-year
3years-OS Rate
Time frame: 3-years
5years-OS Rate
Time frame: 5 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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Feng Shen principal investigator
Eastern Hepatobiliary Surgery Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Organoid Drug Sensitivity Testing-Guided Therapy in people with Hepatocellular Carcinoma Resectable, run by Eastern Hepatobiliary Surgery 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 22 inclusion and 32 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: opening soon, as of the sponsor's last update on 23 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kui Wang (+86 13636330827, wangkuiykl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survial(RFS) (time frame: Up to approximately 5 years). The study lists 4 primary outcomes in all. 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 23 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.