Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in
Western countries, and its incidence has increased over the last 40 years. Curative surgery
to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of
patients is diagnosed with locally advanced tumors and/or metastases because they lack
specific symptoms and early markers for this disease. For these patients, palliative
armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more
recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for
PDAC is still very poor and there is great need for new treatments that can change this poor
outcome. In this context, the investigators have devised, in the past few years, a highly
innovative approach based on therapeutic gene transfer, which does not rely on a specific
genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that
SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit
tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of
these promising preclinical data, the investigators conducted past three years the first
clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy
(EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and
metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed
in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the
bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor
progression and dissemination. Our results tend to demonstrate therapeutic efficacy,
especially in patients with locally advanced tumors. Based on these encouraging results, the
investigators propose that patients with locally advanced PDAC at the time of diagnosis may
clinically benefit from this approach.
This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of
CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Toulouse
Collaborators:
BIOTHERAPY department of the clinical center of investigation- CIC 1436, Toulouse InvivoGen Therapeutics