Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator