Safety and efficacy of adding immunotherapy to the standard of care for locally advanced pancreatic cancer patients (LAPC-2 trial).

Phase 1

• Conditions: ocally advanced pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000216-29-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

•Histologically confirmed pancreatic cancer, as indicated by a definite cytology report.
•Tumor considered locally advanced after diagnostic work-up including CT-imaging, using the DPCG criteria for locally advanced disease [26] and diagnostic laparoscopy.
•Age > 18 years and < 75 years.
•WHO performance status of 0 or 1.
•ASA classification I or II.
•No evidence of metastatic disease.
•Largest tumor size < 7 cm x 7 cm x 7 cm.
•No direct tumor involvement oft he stomach, colon or small bowel.
•Normal renal function (Creatinine = 30 ml/min).
•Normal liver tests (bilirubin < 1.5 times normal*; ALAT/ASAT < 5 times normal).
•Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l).
•Ability to wear an Actiwatch device on non-dominant arm.
•Effective contraceptive methods.
•Written informed consent.

* If bilirubin is higher than 35 umol/L placement of a metal biliary stent is mandatory.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior radiotherapy, chemotherapy other than FOLFIRINOX or pancreatic resection.
•Current or previous treatment with immunotherapeutic drugs.
•Previous allergic reaction to any mycobacterial product.
•Prolonged systemic corticosteroid or immunosuppressant medication use (i.e. >2 weeks).
•Lymph node metastases from primary tumor outside the field of radiation.
•Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously to diagnosis of pancreatic cancer and without evidence of recurrence.
•Pregnancy, breast feeding.
•Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
•An active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
•Known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
•Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
•Live virus vaccine within 30 days of planned start of trial treatment.
•Use of herbal remedies, including traditional Chinese herbal products (e.g., mistletoe).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified