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

NCT07363356 | Not Yet Recruiting Phase 2

• 1 other identifier: EHBHKY2025-H030-P001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma Resectable

Keywords

organoid;; drug-sensitive test;; adjuvant therapy

Outcome Measures

Primary Outcomes (4)

• Recurrence-free Survial(RFS)

  Up to approximately 5 years

• 1year-RFS rate

  1-years

• 3years-RFS Rate

  3-years

• 5years-RFS Rate

  5-years

Secondary Outcomes (5)

• Overall Survival（OS）

  Up to approximately 5 years

• Incidence of Adverse Events (AEs)

  Up to approximately 4 years

• 1year-OS rate

  1-year

• 3years-OS Rate

  3-years

• 5years-OS Rate

  5 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Organoid Drug Sensitivity Testing-Guided Therapy

Interventions

Organoid Drug Sensitivity Testing-Guided Therapy DRUG

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.

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Hematological:
• Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L
• Platelet count (PLT) ≥75 × 10⁹/L
• Hemoglobin (HGB) ≥9.0 g/dL
• Hepatic:
• Total Bilirubin (TBIL) ≤3 × Upper Limit of Normal (ULN)
• Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤5 × ULN

You may not qualify if:

• 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:
• Chinese herbal medicines with clear anti-tumor properties.
• 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:
• 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.
• 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:
• 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).
• Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

the Third Affiliated Hospital of Naval Medical University, Shanghai, Shanghai 200433/201805

Shanghai, China

Location

Study Officials

• Feng Shen

  Eastern Hepatobiliary Surgery Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kui Wang

CONTACT

+86 13636330827; wangkuiykl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 23, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)