ACTRN12622000378729
Recruiting
Phase 2
Investigating the safety and efficacy of NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT.
Australasian Gastro-Intestinal Trials Group (AGITG)0 sites20 target enrollmentMarch 3, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pancreatic cancer
- Sponsor
- Australasian Gastro-Intestinal Trials Group (AGITG)
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pancreatic adenocarcinoma proven by histology or cytology that is resectable or borderline resectable.
- •Good performance status (ECOG 0 \- 1\)
- •Adequate kidney, liver and bone marrow function to be able to undergo immuno\-chemotherapy
- •Body weight above 30kg
- •Life expectancy of at least 12 weeks
- •Tumour lesion on CT or MRI scan that is measurable
Exclusion Criteria
- •Locally advanced or metastatic pancreatic adenocarcinoma.
- •Neuroendocrine pancreatic carcinoma.
- •Prior treatment for pancreatic cancer (including another clinical trial).
- •Complete or intermediate dihydropyrimidine dehydrogenase deficiency (DPYD deficiency)
- •Major surgical procedure within 28 days prior to the first dose of immuno\-chemotherapy.
- •History of allogenic organ transplantation.
- •Active or prior autoimmune or inflammatory disorders such as inflammatory bowel disease (eg. colitis, Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis).
- •Uncontrolled intercurrent illness (such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrheoa, psychiatric illness/social situations that would limit compliance with study requirements).
- •History of another primary malignancy (except malignancy treated with curative intent and with no know active disease for more than 5 years, or adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma insitu without evidence of disease or history of leptomeningeal carcinomatosis or history of active primary immunodeficiency).
- •Active infection with TB, hepatitis B or hepatitis C.
Outcomes
Primary Outcomes
Not specified
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