Resected Pancreatic Adenocarcinoma Patients
Conditions
Interventions
treatment group:Olaparib combo Durvalumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; 2.Provision of signed and dated, written informed consent form prior to HRR gene testing; 3.Subjects are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up; 4.Aged 18 to 79 years inclusive, at the time of signing the informed consent form; 5.Individuals with histologically proven pancreatic ductal adenocarcinoma, undergone macroscopically complete resection (R0 or R1 resection); 6.Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: (1) Haemoglobin >= 10.0 g/dL with no blood transfusion in the past 28 days; (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (3) Platelet count >= 100 x 10^9/L; (4) Total bilirubin = 51 mL/min using the Cockcroft-Gault equation or based on a 24 hours urine test: Estimated creatinine clearance =(140-age [years]) x weight (kg)(x F)/(serum creatinine (mg/dL) x 72) where F=0.85 for females and F=1 for males. 7.Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see Table 9); 8.Patients must have a life expectancy >= 16 weeks; 9.Documented mutation in tumour HRR that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); 10.Serum CA19-9 30 Kg will be inclusive; 14.Both male and female will be inclusive; 15.Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1; Postmenopausal is defined as: (1) Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments; (2) Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50; (3) Radiation-induced oophorectomy with last menses >1 year ago; (4) Chemotherapy-induced menopause with >1 year interval since last menses; (5) Surgical sterilisation (bilateral oophorectomy or hysterectomy); 16.Male patients must use a condom during treatment and for 3 months after the last dose of Olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception ([see appendix H for acceptable methods]) if they are of childbearing potent
Exclusion criteria
Exclusion criteria: 1.HRR mutations that are considered to be non-detrimental (eg, Variants of uncertain clinical significance or Variant of unknown significance or Variant, favour polymorphism or benign polymorphism etc.; 2.Recurrence of tumour between start of adjuvant therapy for resected pancreatic cancer patients and enrolment; 3.Concomitant use of know potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir. For further detail refer to Appendix H (POLO protocol); 4.Other malignancy unless curatively treated with no evidence of disease for >= 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma; 5.Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome; 6.Persistent toxicities ( > Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia; 7.Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML; 8.Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days; 9.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, serious chronic gastrointestinal conditions associated with diarrhea, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent; 10.Active or prior documented active primary immunodeficiency, autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: (1)Patients with vitiligo or alopecia; (2)Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; (3)Any chronic skin condition that does not require systemic therapy; (4)Patients without active disease in the last 5 years may be included but only after consultation with the study physician; (5)Patients with celiac disease con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year DFS;3-year overall survial (OS); | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed