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NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer
To determine the safety and tolerability of adding durvalumab to mFOLFIRINOX prior to surgery in patients with resectable or borderline resectable pancreatic adenocarcinoma.
Study details:
Despite curative surgery, pancreatic cancer patients have five-year survival rates of 20%. Adjuvant chemotherapy has improved survival in resected pancreatic cancer patients but only 10-15% are suitable for surgery and 30% of the resected pancreatic cancer patients miss out on adjuvant chemotherapy due to postoperative complications. Neoadjuvant chemotherapy has improved the resection rates in the patients with non-metastatic pancreatic cancer.
There is a growing interest to combine chemotherapy with checkpoint inhibitors to improve disease control in the early stage of pancreas cancer. The investigators propose a pilot study to evaluate the feasibility and safety of combining modified FOLFIRINOX (mFOLFIRINOX) with durvalumab (MEDI4736) in patients with resectable or borderline resectable pancreatic adenocarcinoma.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-05-20
Primary completion: 2024-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06094140
Intervention or treatment
DRUG: Durvalumab
DRUG: Oxaliplatin
DRUG: Irinotecan
DRUG: Calcium folinate (leucovorin)
DRUG: Fluorouracil
DRUG: Pegylated G-CSF
Conditions
- • Pancreatic Cancer
Find a site
Closest Location:
GenesisCare North Shore
Research sites nearby
Select from list below to view details:
GenesisCare North Shore
Sydney, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Warringal Private Hospital
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Single arm study, mFOLFIRINOX and durvalumab, neoadjuvant resectable pancreatic cancer.
| DRUG: Durvalumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
The proportion of patients receiving at least 80% of planned neoadjuvant treatment. | 80% of planned neoadjuvant treatment is defined as at least 5 cycles of mFOLFIRINOX and at least 2 of 3 cycles durvalumab. Dose modified cycles count towards received treatment. Justification: As a pilot study, this primary objective addresses feasibility. A phase II study assessing use of neoadjuvant FOLFIRINOX in borderline resectable pancreatic cancer patients has previously demonstrated an 80% rate of receipt of all planned neoadjuvant therapy (Murphy et al 2018). | At completion of neo-adjuvant treatment (at 3 months post enrollment) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
The proportion of patients missing surgery due to significant treatment related adverse events. | Address efficacy and safety of patients missing surgery due to significant treatment related adverse events. | Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy. |
Treatment tolerability (Rates of adverse events as per CTCAE v5.0). | Address efficacy and safety of treatment tolerability | Through study completion, an average of 1 year |
R0 resection rate. | Address efficacy and safety of the R0 resection rate. | Through study completion, an average of 1 year |
Pathological complete response rate. | Address efficacy and safety of the pathological complete response rate. | Through study completion, an average of 1 year |
Objective response rate. | Address efficacy and safety of the objective response rate. | Through study completion, an average of 1 year |
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