Intera 3000 Hepatic Artery Infusion Pump for Intrahepatic Cholangiocarcinoma:
In a single arm, prospective Phase II clinical trial, patients treated with HAI therapy along with systemic chemotherapy
- Reached median overall survival of 25.0 months (95%CI, 20.6-not reached), and the 1-year OS rate of 89.5% (95%CI, 80.2%-99.8%).
- Twenty-two patients (58%) achieved a partial radiographic response, and 32 patients (84%) achieved disease control at 6 months. Four patients had sufficient response to undergo resection, and 1 patient had a complete pathologic response.
- The median progression free survival was 11.8 months (1-sided 90% CI, 11.1) with a 6-month PFS rate of 84.1%(90% CI, 74.8%-infinity), thereby meeting the primary end point (6-month PFS rate, 80%).
- Patients with resectable regional lymph nodes (18 [47%]) showed no difference in OS compared with patients with node-negative disease.
- In a confirmatory phase I/II study of 10 patients at a separate hospital, 9 patients (90%) achieved disease control at 6 months;
Study limitations: there is the possibility of selection bias owing to small sample size.