Pancreatic Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.
Detailed description
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer. The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.
Interventions
DRUGH101
H101 15x10\^11vp intratumorally injection starts at day 1.
DRUGCamrelizumab
Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Oncolytic virus plus PD-1 inhibitor
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ability to understand and the willingness to sign a written informed consent document. * Age ≥ 18 years and ≤ 80 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Histologically or cytologically confirmed advanced pancreas adenocarcinoma. * Patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy. * Locally advanced, or metastatic pancreatic cancer. * Presence of at least of one measurable lesion in agreement to RECIST criteria. * The expected survival ≥ 3 months. * Adequate organ performance based on laboratory blood tests. * Patients who are willing or able to comply with study procedures.
Exclusion criteria
* Pregnant or nursing women. * Primary pancreatic cancer, or prior treatment with oncolytic virus and PD-1 inhibitor. * The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. * Allergic to study drugs. * Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival，OS | At the end of Cycle 1 (each cycle is 21 days) | OS of subjects from recruiting to the time of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival, PFS | At the end of Cycle 1 (each cycle is 21 days) | PFS of subjects from recruiting to the time of disease progression |
| objective response rate (ORR) | At the end of Cycle 1 (each cycle is 21 days) | CR + PR |
| disease control rate (DCR) | At the end of Cycle 1 (each cycle is 21 days) | CR + PR + SD |
Contacts
Primary ContactYing Yang, MD
Backup ContactGuopei Luo, MD
Outcome results
None listed