Gene therapy and chemotherapy for pancreatic cancer: clinical study of safety and efficacy

Phase 1

• Conditions: ocally advanced pancreatic adenocarcinoma; MedDRA version: 20.0Level: PTClassification code 10073364Term: Ductal adenocarcinoma of pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000588-53-IT
• Lead Sponsor: RIGENERAND Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

a) Patients with histologically and/or cytologically confirmed pancreatic ductal adenocarcinoma
b) Patients with no evidence of peritoneal or hematogenous metastasis
c) Patients classified as non-resectable locally advanced pancreatic carcinoma (LAPC) based on imaging (TC and NMR), on multidisciplinary staff evaluation by at least an oncologist, radiologist and a qualified digestive surgeon and accounting for AJCC/UICC TNM and clinical staging.
d) Measurable tumor according RECIST criteria v 1.1
e) Low tumor burden with at least one lesion equal/less than 3,5 cm that is suitable for US guided injection (and needle biopsy).
f) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
g) Patients must be eligible for standard of care treatment with GEM/Nab-PTX
h) Patient older than 18 years of age
i) Evidence of a personally signed and dated Ethical Committee-approved Informed consent form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
j) Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN
k) Adequate kidney function with serum creatinine <2 x the ULN or creatinine clearance >30 mL/min
l) Absolute neutrophil count (ANC) =1.0 x 109/l, hemoglobin =9 g/dl, platelet count = 100 x 109/l, prothrombin (INR) <1.5.
m) Life expectancy of at least 12 weeks
n) Negative serum pregnancy test for females of childbearing potential within days of starting treatment
o) Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

a)Female patients with childbearing age or pregnancy or breast feeding. Female patients shall agree to use effective contraception or be surgically sterile or postmenopausal.
b)Patient with pancreatic cystic tumor or pancreatic pseudocyst
c)Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)
d)Patients with unknown stage or recurrent pancreatic cancer
e)Patients with immunosuppression or susceptibility to viral infection
f)Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections
g)Patients with liver cirrhosis or other documented liver diseases
h)Patient contraindication to gemcitabine + nab-paclitaxel treatments
i)Patients with not approachable US window for intratumoral injection of RR001 as evaluated by US examination of the abdomen
j)Documented allergy to fluoroquinolones
k)Previous of radiotherapy and chemotherapy for PDAC
l)Previous haematopoietic stem cell or organ transplantation
m)Irreversible cardiac arrhythmias requiring permanent medication
n)Heart insufficiency (> grade II, New York Heart Association NYHA criteria)
o)History within the last year of acute or subacute coronary cyndromes including myocardial infarction, unstable or severe stable angina pectoris
p)Uncontrolled hypertension
q)Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis
r)Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma, in situ melanoma).
s)Moderate to large volume ascites
t)Active autoimmune disease
u)Use of any investigational agents within 21 days from the administration of study treatment
v)Patient has had major open surgery within the 3 months prior to the administration of study treatment
w)Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk

Study & Design

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