Biliary Malignant Tumors
Conditions
Brief summary
The primary objective of this study is to evaluate the safety of iNeo-Vac-R01, an individualized mRNA therapeutic technology based on tumor neoantigens, for the adjuvant treatment of patients with biliary malignant tumors after radical resection.
Interventions
BIOLOGICALiNeo-Vac-R01
IH injection
Sponsors
Yifan Wang
Hangzhou Neoantigen Therapeutics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, \>/= 18 years old and \</= 75 years old； 2. Biliary malignant tumors confirmed by histopathological or cytological examination that are eligible for radical resection； 3. Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms, have measurable disease at study entry defined by RECIST v1.1. Subjects must have tumor progression after standard treatment or are intolerant or are unwilling to receive standard treatment. The toxic effects of previous anti-tumor treatments have returned to \</= grade 1 defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 or to the level specified by the inclusion/
Exclusion criteria
. 4. Expected survival \>/= 6 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 \~ 1； 6. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood； 7. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \>/= 50%. 8. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \>/= 1.5 × 10\^9/L, platelet count (PLT) \>/= 80 × 10\^9/L, hemoglobin (Hb) \>/= 90 g/L; serum total bilirubin (TBIL) \</= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \</= 2.5 × ULN (if there is liver metastasis, TBIL \</= 3 × ULN, AST, ALT \</= 5 ×ULN are allowed), serum albumin \>/= 28g/L, serum creatinine \</= 1.5 × BUN, Glomerular filtration rate \>/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \</= 1.5 × ULN (without anticoagulant therapy) . 9. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period. 10. For men: agreement to remain abstinent or use contraceptive measures during the treatment period. 11. Able to comply with the study protocol and follow-up procedures. 12. 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 subjects), a witness shall be present to observe the informed consent process and sign the informed consent form on their behalf.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose for Safety and Tolerability Evaluation | 21 days after last iNeo-Vac-R01 dose | Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, the number of subjects with adverse events and/or dose-limiting toxicities will be counted as indicators for evaluating the safety and tolerability dose of iNeo-Vac-R01 Injection. The safety data collection visit will be conducted at 21 days after the last treatment administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 years after first dose of iNeo-Vac-R01 | OS is defined as time between the date of the first dose of iNeo-Vac-R01 and the date of death due to any cause. |
| Relapse-Free Survival (RFS) | 3 years after first dose of iNeo-Vac-R01 | The time from the date of the first administration of iNeo-Vac-R01 Injection to the date of disease recurrence or death from any cause. The assessment duration is 3 years. |
Countries
China
Contacts
CONTACTYifan Wang
Outcome results
None listed