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New treatment option for Advanced Hepatocellular Carcinoma (HCC)
Official title Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06995105
What this study is testing
What is Sintilimab combined with Bevacizumab?
Sintilimab combined with Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced 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 study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody, anti-VEGFR monoclonal antibody and TACE regimen for the treatment of patients with advanced hepatocellular carcinoma.
- 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
- (1) people who meet all the following will enter the pre-screening stage of this study and undergo the lesion puncture process:
- Voluntarily sign the informed consent form;
- Aged ≥18 years and ≤75 years, regardless of gender;
- Strictly meet the 2018 American Association for Clinical Diagnosis of Liver Diseases (AASLD) clinical diagnostic criteria for HCC, and imaging...
- Have not received systemic or local treatment for HCC in the past.
You likely can't join if
- 1) Diffuse HCC. 2) Known fibrolamellar HCC, cholangiocarcinoma, and mixed HCC. 3) Concomitant tumor thrombus in the main portal vein or contralateral...
- 4) History of meningeal disease; presence of central nervous system metastases or meningeal metastases.
- 5) History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia...
- 6) Patients with other malignant tumors at the same time, but basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc. that have...
- 15) Pregnant or lactating women; 16) Those who the investigators believe are not suitable for inclusion or may not be able to complete this trial for...
See the full eligibility criteria
- (1) people who meet all the following will enter the pre-screening stage of this study and undergo the lesion puncture process:
- Voluntarily sign the informed consent form;
- Aged ≥18 years and ≤75 years, regardless of gender;
- Strictly meet the 2018 American Association for Clinical Diagnosis of Liver Diseases (AASLD) clinical diagnostic criteria for HCC, and imaging assessment is unresectable/metastatic hepatocellular carcinoma (HCC), CNLC...
- Have not received systemic or local treatment for HCC in the past.
- According to the solid tumor how well it works evaluation criteria (RECIST 1.1), the investigators assess the presence of measurable lesions.
- Child-Pugh score within 7 points (including 7 points)
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
- Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;
- The main organ functions of the heart, liver and kidney are normal:
- QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;
- Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
- Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
- Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed...
- Male patients with fertility and female patients of childbearing age agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration of the trial...
- Able to follow the study protocol and follow-up process. (2) people who meet all the following will enter the formal screening phase of this study and enter the study medication process:
- Voluntarily sign the informed consent form;
- Aged ≥18 years and ≤75 years, regardless of gender;
- Primary hepatocellular carcinoma confirmed by pathology (histology or cytology);
- Have not received any systemic treatment.
- According to the solid tumor how well it works evaluation criteria (RECIST 1.1), the researcher assesses the presence of measurable lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Normal function of the heart, liver and kidney:
- QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;
- Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
- Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
- Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed...
- Male patients with fertility and female patients of childbearing age agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration of the trial...
- Able to follow the study protocol and follow-up process.
- 1) Diffuse HCC. 2) Known fibrolamellar HCC, cholangiocarcinoma, and mixed HCC. 3) Concomitant tumor thrombus in the main portal vein or contralateral portal vein, superior mesenteric vein, or vena cava.
- 4) History of meningeal disease; presence of central nervous system metastases or meningeal metastases.
- 5) History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening chest CT.
- 6) Patients with other malignant tumors at the same time, but basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc. that have been cured, have been in a disease-free state for more than 5 years or...
- 15) Pregnant or lactating women; 16) Those who the investigators believe are not suitable for inclusion or may not be able to complete this trial for other reasons.
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.