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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
individualized anti-tumor new antigen iNeo-Vac-R01 injection
Biological/VaccineThe individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.
Gemcitabine + cisplatin (GP)
DrugAs standard chemotherapy (D1, D8 gemcitabine 1000mg/m², intravenous drip for 30 minutes, cisplatin 25mg/m², intravenous drip), once every 3 weeks
Sintilimab injection
DrugSintilimab Injection, 200mg, intravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
Safety and tolerable 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.
Secondary outcomes
Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Progression-free survival (PFS)
The time from enrolled to disease pregression or death from any cause during the whole study.
Overall survival (OS)
The time from enrolled to death from any cause during the whole study.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator