PANCEP-1
- Conditions
- Pancreatic cancerTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506979-10-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1.Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution., 2.Patient is a male or female age >18, 3.By the surgeons evaluation fit for pancreatic surgery, 4.Subjects must have radiologic, and/or cytologic confirmation of primary resectable pancreatic or periampullary cancer. Pancreatic ductal adenocarcinoma, ampullary carcinoma and cholangiocarcinoma are the most common forms, but also other rare forms of pancreatic and periampullary cancer may be included.
1.Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 6 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease., 2.History of uncontrolled seizures, severe central nervous system disorders, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol., 3.Ongoing treatment with immunomodulating medication, i.e. corticosteroids., 4.Ongoing active peptic ulcer., 5.Ongoing asthma., 6.Any other condition or symptoms preventing the patient from entering the study, according to the PI's judgement., 7.A woman of childbearing potential (WOCBP) must agree to comply with using an effective contraceptive method for the duration of the treatment (a WOCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Local laws and regulations may require use of alternative and/or additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the frequency and extent of adverse events associated with the therapy.;Secondary Objective: To determine the clinical efficacy of peri- and postoperative treatment with HDC/IL-2 in patients with primary resectable pancreatic cancer using matched, contemporary control patients as the comparator., To investigate the efficacy of peri- and postoperative therapy with HDC/IL-2 vs. control patients in the IPEP study on certain biomarkers relating to inflammation and/or immune responses.;Primary end point(s): The safety and tolerability of the treatment will be evaluated by the assessment of all adverse events (AEs) occurring during treatment—both those considered treatment-related and unrelated. Adverse events will be collected from Cycle 1 Day 1 through the final study visit and will be graded for severity according to the NCI-CTCAE, version 5.0. Safety will also be evaluated by clinical laboratory tests, physica
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Secondary Efficacy Variables: Progression-free survival and overall survival;Secondary end point(s):Secondary Outcome Biomarker Variables: •NK cell subsets in blood, including immature (CD16-) and cytotoxic (CD16+) subsets, activation markers, natural cytotoxicity receptors including NKp30, NKp46 and NKG2D, killer-immunoglobulin receptors. •T cell subsets including CD4+/25 regulatory T cells and naive, central memory, effector memory and effector CD8+ T cells;Secondary end point(s):continuation Secondary Outcome: Biomarker Variables: •Myeloid cell populations including granulocytes and monocytes, MDSC, dendritic cells, activation markers, PD-L1, PD-L2 and related immune biomarkers. •Serum CA 19-9 •Serum levels of cytokines, chemokines and other soluble mediators of inflammation •Amount of tumor-infiltrating lymphocytes (TILs) and tumor-infiltrating myeloid cells