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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • individualized anti-tumor new antigen iNeo-Vac-R01 injection

    Biological/Vaccine

    The 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)

    Drug

    As standard chemotherapy (D1, D8 gemcitabine 1000mg/m², intravenous drip for 30 minutes, cisplatin 25mg/m², intravenous drip), once every 3 weeks

  • Sintilimab injection

    Drug

    Sintilimab Injection, 200mg, intravenous infusion

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: AExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
21±3 days after the last dose

Secondary outcomes

1

Objective reponse rate (ORR)

The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study

Time frame
Up to 2 years
2

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.

Time frame
Up to 2 years
3

Progression-free survival (PFS)

The time from enrolled to disease pregression or death from any cause during the whole study.

Time frame
Up to 2 years
4

Overall survival (OS)

The time from enrolled to death from any cause during the whole study.

Time frame
Up to 2 years

Other outcomes

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