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New treatment option for Advanced Intrahepatic Cholangiocarcinoma
Official title Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06956716
What this study is testing
What is individualized anti-tumor new antigen iNeo-Vac-R01 injection?
individualized anti-tumor new antigen iNeo-Vac-R01 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced intrahepatic cholangiocarcinoma.
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
- The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma.
- 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;
- Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;
- Have not received systemic or local treatment.
You likely can't join if
- If the subject meets any of the following criteria, he/she will be excluded from this study:
- Those who suffer from other malignant tumors at the same time, but have been cured of basal cell carcinoma, thyroid cancer, cervical atypical...
- Those who have received a history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell...
- Those who are accompanied by immunosuppressants, that is, those who need to take immunosuppressants regularly 4 weeks before the screening period and...
- Active bacterial or fungal infection confirmed by clinical diagnosis; active tuberculosis or history of tuberculosis;
- Positive test results for human immunodeficiency virus (HIV) antibody, positive test results for Treponema pallidum (TP), active hepatitis C...
See the full eligibility criteria
Who can join
- (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;
- Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;
- Have not received systemic or local treatment.
- According to the solid tumor how well it works evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;
- Normal function of the main organs 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 and female patients of childbearing age with fertility agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the trial drug; women of...
- Able to follow the study protocol and follow-up procedures. (2) people who meet all the following will enter the formal screening stage of this study and enter the study medication process:
- Voluntary signing of the informed consent form;
- Age ≥ 18 years and ≤ 75 years, regardless of gender;
- Intrahepatic cholangiocarcinoma 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 investigators assessed the patients as having measurable lesions.
- The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1;
- The major organ functions of the heart, liver, and kidney were 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.
What rules you out
- If the subject meets any of the following criteria, he/she will be excluded from this study:
- Those who suffer from other malignant tumors at the same time, but have been cured of basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc., have been in a disease-free state for more than 5 years or...
- Those who have received a history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
- Those who are accompanied by immunosuppressants, that is, those who need to take immunosuppressants regularly 4 weeks before the screening period and during the clinical study, including but not limited to the following...
- Active bacterial or fungal infection confirmed by clinical diagnosis; active tuberculosis or history of tuberculosis;
- Positive test results for human immunodeficiency virus (HIV) antibody, positive test results for Treponema pallidum (TP), active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA), active...
- Herpes virus infection (except for those with scabs for more than 4 weeks); respiratory virus infection (except for those who have recovered for more than 4 weeks);
- Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases...
- History of drug abuse, clinical, psychological or social factors that affect informed consent or research implementation; history of mental illness;
- History of food, drug or vaccine allergy, or other potential immunotherapy allergy considered by the investigator.
- Pregnant or lactating women;
- Those who the investigator considers unsuitable 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.