About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- individualized anti-tumor new antigen iNeo-Vac-R01 injection
- Gemcitabine + cisplatin (GP)
- Sintilimab injection
Treatment groups
Sponsors and collaborators
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator