Not Yet RecruitingPhase 2

Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer

China56 participantsStarted 2026-01-30

Plain-language 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 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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):

What they're measuring

Recurrence-free Survial(RFS)

Timeframe: Up to approximately 5 years

1year-RFS rate

Timeframe: 1-years

3years-RFS Rate

Timeframe: 3-years

5years-RFS Rate

Timeframe: 5-years

Trial details

NCT IDNCT07363356

SponsorEastern Hepatobiliary Surgery Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Kui Wang

+86 13636330827 wangkuiykl@163.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma Resectable trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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):

Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria