fig2

Figure 2. CONSORT flow-chart of the Thergap-2 clinical protocol of gene therapy for locally advanced PDAC. This flow-chart illustrates the progression of patients through the Thergap-2 clinical trial. Seventy-two patients were initially assessed for eligibility. Two patients were excluded due to the presence of metastases at screening. Seventy patients were randomized into two arms: Arm A (*): thirty-five patients were included in the ITT population. Twenty-six patients adhered to the protocol without violations of inclusion and exclusion criteria, receiving at least 3 weeks of gemcitabine and two CYL-02 intratumoural injections. Thirty-one patients were evaluable for tolerance and received at least one administration of the treatments. (*): Four patients did not receive allocated treatment due to the following reasons: borderline tumor (n = 1), pelvic fracture with inability to perform endoscopic ultrasound, persistent thrombocytopenia with grade 2 portal hypertension, and inability to inject CYL-02 due to pyloric suture after surgical digestive bypass. Arm B (**): thirty-five patients were included in the ITT population. Thirty-one patients adhered to the protocol without violations of inclusion and exclusion criteria, receiving at least 3 weeks of gemcitabine. Thirty-four patients were evaluable for tolerance and received at least one administration of the treatment. (**): One patient did not receive the allocated treatment because the patient withdrew consent. Definitions: ITT includes all randomized patients, treated or not, eligible or not. Per-Protocol includes all patients without violation of inclusion and exclusion criteria and receiving at least 3 weeks of gemcitabine (Arms A and B) as well as two CYL-02 intratumoural injections (Arm A). Safety includes all patients evaluable for tolerance and who received at least one administration of either treatment. PDAC: Pancreatic ductal adenocarcinoma; ITT: intent-to-treat.