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Trial Title:
Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer
NCT ID:
NCT06196671
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Oncolytic virus plus PD-1 inhibitor
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
H101
Description:
H101 15x10^11vp intratumorally injection starts at day 1.
Arm group label:
Oncolytic virus plus PD-1 inhibitor
Other name:
Oncolytic virus
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
Arm group label:
Oncolytic virus plus PD-1 inhibitor
Other name:
pd-1 inhibitor
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196671
