Pancreatic Cancer Metastatic, Pancreatic Cancer Non-resectable
Conditions
Brief summary
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.
Interventions
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.
continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
Sponsors
Hangzhou Neoantigen Therapeutics Co., Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
(1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study: 1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines; 4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1); 7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis; 8. Main organ function of heart, liver and kidney is normal: 9. 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; 10. 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: 1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology); 4. No systemic treatment or gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. Main organ function of heart, liver and kidney is normal: 7. 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; 8. Ability to follow the study protocol and follow-up procedures.
Exclusion criteria
Subjects will be excluded from this study if they meet any of the following criteria: 1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis; 2. 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; 3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; 4. 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; 5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis; 6. 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; 7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks); 8. 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; 9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness; 10. Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator. 11. Women born during pregnancy or lactation; 12. The investigator is not fit for enrollment or may not complete the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence and frequence of AE and SAE | Up to 2 years | Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Up to 2 years | 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） | Up to 2 years | The time from enrolled to disease pregression or death from any cause during the whole study. |
| Objective reponse rate (ORR) | Up to 2 years | The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study |
| Progression-free survival Rate（1-Y-PFS%, 2-Y-PFS%,3-Y-PFS%） | Up to 3 years | The proportion of patients free from disease progression or death (whichever occurs first) at 12, 24, and 36 months. |
| Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%) | Up to 3 years | The percentage of patients surviving at 12, 24, and 36 months. |
| Overall survival (OS) | Up to 2 years | The time from enrolled to death from any cause during the whole study |
Countries
China
Contacts
Primary ContactTingbo Liang, MD., PhD.
Backup ContactYiwen Chen, MD.
Outcome results
None listed