NCT06956716招募中1 期
Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy in Combination With PD-1 Antibody and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma
Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月9日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerable dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Subjects who meet all the following inclusion criteria 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 efficacy 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 for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
- •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 childbearing age include premenopausal women and women within 2 years after menopause;
- •Able to follow the study protocol and follow-up procedures.
- •(2) Subjects who meet all the following inclusion criteria 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 efficacy 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 for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
- •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 drug; women of childbearing age include premenopausal women and women within 2 years after menopause;
- •Able to follow the study protocol and follow-up process.
排除标准
- •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 are considered by the researchers to be less likely to relapse;
- •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 situations: those with severe asthma, autoimmune diseases or immunodeficiency, those who are treated with immunosuppressive drugs, and those with a known history of primary immunodeficiency; but type 1 diabetes, autoimmune-related hypothyroidism requiring hormone treatment, and vitiligo and psoriasis that do not require systemic treatment are excluded;
- •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 hepatitis B;
- •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 that the investigator considers unsuitable for inclusion;
- •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.
研究组 & 干预措施
A
Experimental
干预措施: individualized anti-tumor new antigen iNeo-Vac-R01 injection (Biological)
A
Experimental
干预措施: Gemcitabine + cisplatin (GP) (Drug)
A
Experimental
干预措施: Sintilimab injection (Drug)
结局指标
主要结局
Safety and tolerable dose
时间窗: 21±3 days after the last dose
According to the Commonly Used Adverse Events Criteria (CTCAE Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicity was counted as an indicator of the safety and tolerable dose of iNeo-Vac-R01 injection. The evaluation period was the dosing observation period and the safety follow-up period.
次要结局
- Objective reponse rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival （PFS）(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%)(Up to 3 years)
研究者
TingBo Liang
The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine
First Affiliated Hospital of Zhejiang University
研究点 (1)
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