Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2028

Conditions
Pancreatic CancerSurgeryMetastasisImmunosuppression
Interventions
DRUG

Histamine Dihydrochloride (HDC)

HDC is administrated in combination with IL-2 as peri- and post-operative treatment in patients undergoing surgery. 0.5 mg HDC is administered twice daily by subcutaneous injections 1 to 3 minutes after each IL-2 injection during three 3 week cycles, with 3-week resting periods inbetween. The first treatment cycle is initated 2 weeks prior to surgery, with an additional 2-3 days rest period during the surgical procedure, before the third treatment week is initiated.

DRUG

Interleukin-2 (IL-2)

IL-2 is administrated in combination with HDC during three 3 week cycles as peri- and post-operative treatment in patients undergoing surgery. IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of histamine dihydrochloride; each dose of IL-2 is 16,400 IU/kg (1µg/kg).

All Listed Sponsors
lead

Sahlgrenska University Hospital

OTHER

NCT05810792 - Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer | Biotech Hunter | Biotech Hunter