Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

Официальное название

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.

Обзор

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

Вмешательства

• Биопрепарат individualized anti-tumor new antigen iNeo-Vac-R01 injection
  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.
• Препарат mFOLFIRINOX Treatment Regimen
  continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
• Препарат Sintilimab injection
  Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks

Первичные конечные точки

• Occurence and frequence of AE and SAE [Срок оценки: Up to 2 years]

Вторичные конечные точки (6)

• Objective reponse rate (ORR) [Срок оценки: Up to 2 years]
• Disease control rate (DCR) [Срок оценки: Up to 2 years]
• Progression-free survival （PFS） [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to 2 years]
• Progression-free survival Rate（1-Y-PFS%, 2-Y-PFS%,3-Y-PFS%） [Срок оценки: Up to 3 years]
• Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

(1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study:

• Voluntary signing of the informed consent form;
• Age: 18 and 75 years old, male or female;
• Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;
• No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.
• An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;
• According to the efficacy evaluation criteria for solid tumors (RECIST 1.1);
• Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis;
• Main organ function of heart, liver and kidney is normal:
• Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause;
• Ability to follow the study protocol and follow-up procedures.

(2) Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process:

• Voluntary signing of the informed consent form;
• Age: 18 and 75 years old, male or female;
• Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology);
• No systemic treatment or gemcitabine-based first-line chemotherapy.
• An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;
• Main organ function of heart, liver and kidney is normal:
• Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause;
• Ability to follow the study protocol and follow-up procedures.

Критерии исключения

Subjects will be excluded from this study if they meet any of the following criteria:

• Pancreatic cancer has central nervous system metastasis or meningeal metastasis;
• At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;
• History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
• Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;
• Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;
• Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B;
• Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks);
• Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator;
• Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness;
• Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator.
• Women born during pregnancy or lactation;
• The investigator is not fit for enrollment or may not complete the trial for other reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Zhejiang University Schlool of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06888648 · CISPD-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗