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Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection
ClinicalTrials.gov ID: NCT07495215
What this study is testing
What is iNeo-Vac-R01?
iNeo-Vac-R01 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells to eliminate tumor cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18 to 75 years old (at the time of signing the informed consent form).
- Patients with histopathologically or cytologically confirmed hepatocellular carcinoma (HCC) eligible for radical resection; no tumor thrombus in the...
- High risk of postoperative recurrence, where high risk is defined as a single tumor lesion with microvascular invasion, or 2-3 tumor lesions...
- Able to complete at least 4 cycles of the standard postoperative adjuvant therapy regimen in accordance with clinical guidelines; and toxicities from...
You likely can't join if
- (Note: Excluding Grade ≤ 2 toxicities such as alopecia, fatigue, or other toxicities assessed by the investigator as having no significant risk).
- Expected survival time of at least 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Sufficient tumor tissue samples can be obtained for genetic analysis: for puncture samples, at least 2 core biopsy tissues with tumor purity ≥ 50%...
- Echocardiography assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Hematological parameters meeting the following requirements: ① Routine blood test criteria
See the full eligibility criteria
Who can join
- Aged 18 to 75 years old (at the time of signing the informed consent form).
- Patients with histopathologically or cytologically confirmed hepatocellular carcinoma (HCC) eligible for radical resection; no tumor thrombus in the portal vein, hepatic vein or bile duct on pre-operative imaging; for...
- High risk of postoperative recurrence, where high risk is defined as a single tumor lesion with microvascular invasion, or 2-3 tumor lesions; intermediate risk is defined as a single tumor lesion with a diameter \> 5 cm...
- Able to complete at least 4 cycles of the standard postoperative adjuvant therapy regimen in accordance with clinical guidelines; and toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 per the National...
What rules you out
- (Note: Excluding Grade ≤ 2 toxicities such as alopecia, fatigue, or other toxicities assessed by the investigator as having no significant risk).
- Expected survival time of at least 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Sufficient tumor tissue samples can be obtained for genetic analysis: for puncture samples, at least 2 core biopsy tissues with tumor purity ≥ 50%; for surgical samples, a soybean-sized tissue sample.
- Echocardiography assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Hematological parameters meeting the following requirements: ① Routine blood test criteria
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L (no red blood cell transfusion within 7 days before the first administration of the mRNA injectable formulation)
- Platelet count ≥ 80 × 10⁹/L ② Biochemical parameter criteria
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
- Serum albumin ≥ 28 g/L
- Serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (per Cockcroft-Gault formula)
- Coagulation function criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (in patients not receiving anticoagulant therapy)
- For pregnant or lactating women: excluded; for women of childbearing potential, negative serum pregnancy test within 7 days before enrollment, no planned pregnancy in the short term, and willingness to adopt effective...
- Male patients are willing to adopt appropriate contraceptive methods.
- Able to comply with the study protocol and follow-up procedures.
- Voluntarily participate in the study and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., illiterate people), a witness shall observe the informed consent process and sign...
- A history of malignancy requiring anti-tumor therapy within 5 years prior to study enrollment (excluding treated Stage I prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, papillary...
- Major surgical treatment, significant traumatic injury within 2 weeks before the first personalized immunotherapy administration; or presence of unhealed wounds or fractures for a long time.
- No eligible neoantigens for personalized immunotherapy identified by sequencing data analysis.
- Planned or prior history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
- Requirement for immunosuppressant therapy, systemic or absorbable local hormonal therapy for immunosuppressive purposes, and continued use within 7 days before the first study drug administration (excluding systemic...
- Receipt of any other vaccine within 4 weeks before study treatment initiation; or anticipated need for any other vaccine during the study treatment period or within 60 days after the last study treatment administration.
- Presence of active or uncontrolled severe infection (including fungal, bacterial, viral or other infections); or active tuberculosis.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range; positive hepatitis C virus (HCV) antibody with peripheral...
- A history of autoimmune disease or immunodeficiency with immunosuppressant therapy (excluding vitiligo, Type 1 diabetes mellitus, autoimmune hypothyroidism requiring hormonal therapy, and psoriasis not requiring...
- Cardio-cerebrovascular events: a history or current diagnosis of Grade ≥ 3 cardiac valvular disease; or heart failure (New York Heart Association [NYHA] Class ≥ II), myocardial infarction, unstable angina pectoris...
- Respiratory diseases: a history or current diagnosis of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, severe asthma, etc.; or patients with complicated...
- Clinically significant moderate to severe ascites; uncontrolled or moderate to large pleural effusion or pericardial effusion.
- Substance abuse; or clinical, psychological or social factors that may affect the informed consent process or study implementation.
- A history of hypersensitivity to prior immunotherapeutic agents or vaccines; or other potential hypersensitivity to immunotherapy as assessed by the investigator.
- Assessed by the investigator as unsuitable for enrollment, or unable to complete the study for other reasons.
- Vulnerable populations, including patients with mental illness, cognitive impairment, critically ill patients, pregnant/lactating women, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.