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New treatment option for Hepatocellular Carcinoma (HCC)
Official title A Phase I Study of CREPT-618 in Locally Advanced HCC
ClinicalTrials.gov ID: NCT07364357
What this study is testing
What is gene therapy?
gene therapy is an investigational medicine, given as an injection under the skin, 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
- This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment. The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose.
- Phase 1: an early, usually small safety study
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
- Age: 18-75 years old.
- Diagnosis: Patients with histologically confirmed locally or advanced hepatocellular carcinoma (HCC) (BCLC stage C or ineligible for curative...
- Hepatitis B Status: Inactive hepatitis B virus infection with negative HBV-DNA viral load.
- Informed Consent: Ability to understand and voluntarily sign the informed consent form.
- Prior Treatment: Failed prior standard treatment.
You likely can't join if
- \- Prior Treatment: a) Received systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy) or...
- Autoimmune Disease: Active autoimmune disease or a history of autoimmune disease within the past 2 years. Exceptions: vitiligo, Graves' disease...
- Severe Liver Decompensation: Presence of any of the following symptoms or abnormal indicators of severe liver function decompensation: Refractory...
- Laboratory Values: Total bilirubin \> 3 mg/dL (51.3 μmol/L) Albumin \ 2.3 or prothrombin time prolongation \> 6 seconds ALT or AST \> 3 times the...
- Severe Infection/Comorbidities:
- Positive for HIV or a known history of AIDS.
See the full eligibility criteria
- Age: 18-75 years old.
- Diagnosis: Patients with histologically confirmed locally or advanced hepatocellular carcinoma (HCC) (BCLC stage C or ineligible for curative treatment).
- Hepatitis B Status: Inactive hepatitis B virus infection with negative HBV-DNA viral load.
- Informed Consent: Ability to understand and voluntarily sign the informed consent form.
- Prior Treatment: Failed prior standard treatment.
- ECOG Performance Status: ECOG performance status score of 0-2.
- Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- Biomarker Status: Must be able to provide at least six unstained slides for testing, confirming both CREPT and ASGPR receptor positivity in liver cancer tissue. Alternatively, a tumor biopsy can be performed to confirm...
- Organ Function: Acceptable major organ function as defined by the following laboratory values: Platelets ≥ 70 × 10\^9/L Neutrophils ≥ 1.5 × 10\^9/L Hemoglobin ≥ 90 g/L Prothrombin time prolongation ≤ 6 seconds Renal...
- Life Expectancy: Expected life expectancy of at least 3 months.
- Contraception: Male and female patients of childbearing potential must agree to use effective contraception (hormonal, barrier, or abstinence) during the study and for at least 6 months after the last dose of the study...
- Compliance: Patients must be compliant and willing to adhere to follow-up procedures.
- \- Prior Treatment: a) Received systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy) or participated in other therapeutic clinical studies within 4 weeks prior to...
- Autoimmune Disease: Active autoimmune disease or a history of autoimmune disease within the past 2 years. Exceptions: vitiligo, Graves' disease, Hashimoto's disease, or psoriasis that did not require systemic treatment...
- Severe Liver Decompensation: Presence of any of the following symptoms or abnormal indicators of severe liver function decompensation: Refractory ascites (unresponsive to diuretics or requiring frequent paracentesis)...
- Laboratory Values: Total bilirubin \> 3 mg/dL (51.3 μmol/L) Albumin \ 2.3 or prothrombin time prolongation \> 6 seconds ALT or AST \> 3 times the upper limit of normal (ALT \> 120 U/L, AST \> 105 U/L) Serum sodium \ 1.5...
- Severe Infection/Comorbidities:
- Positive for HIV or a known history of AIDS.
- Positive for Hepatitis C virus (anti-HCV or HCV-RNA). (Patients with Hepatitis B may be included if they are receiving and willing to continue antiviral treatment according to local guidelines).
- Interstitial lung disease, obstructive lung disease, active bronchospasm, or oxygen saturation \< 93% ("pulmonary insufficiency"), or any other active or severe pulmonary disease that may cause severe respiratory...
- Unresolved Toxicity: Unresolved toxicities from prior anti-cancer treatment that have not recovered to ≤ Grade 1. Exceptions may include toxicities judged by the investigator to not pose a safety risk (e.g., alopecia...
- Comorbidities: Uncontrolled diabetes (fasting blood glucose \> 200 mg/dL or 11.1 mmol/L), severe cardiovascular disease (e.g., myocardial infarction within the last 6 months, unstable angina, NYHA Class III-IV heart...
- Brain Metastases: Patients with symptomatic active brain or meningeal metastases, primary central nervous system (CNS) tumors, or CNS metastases that have failed local treatment. Patients with asymptomatic or stable CNS...
- Other Malignancies: A history of other active malignancies within 5 years prior to enrollment, excluding basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in...
- Vaccination: Received live attenuated vaccines within 28 days prior to the first dose of the study drug. During the study, no vaccines other than inactivated vaccines (e.g., inactivated influenza vaccine) are permitted.
- Prior Immunotherapy: History of immunotherapy (including anti-CTLA-4/anti-PD-L1 or other agents) with any unresolved irAEs \> Grade 1 prior to the first dose, or a history of irAEs ≥ Grade 3. Also, known allergy to any...
- Other: Received liver transplant evaluation or planned liver transplant within 4 weeks prior to the first dose, or planned during the study. Psychological/Compliance Issues: Patients with a mental disorder or poor...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Beijing, 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.