Intrahepatic Cholangiocarcinoma

HAI for Intrahepatic Cholangiocarcinoma:

The Intera 3000 and floxuridine combined with systemic chemotherapy (CT) to treat patients with unresectable intrahepatic cholangiocarcinoma (IHC) has been shown to increase patient overall survival.

 

Adjuvant Therapy

In a single arm, prospective Phase II clinical trial, HAI therapy with systemic chemotherapy was shown to:

  • Provide median overall survival of 25.0 months (95%CI, 20.6-not reached), and the 1-year OS rate was 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.
Adjuvant Therapy
  • 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;

Limitations: there is the possibility of selection bias owing to small sample size.[1]

[1]   Cercek A, Boerner T, Tan BR, et al : Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma A Phase 2 Clinical Trial. JAMA Oncol. L2020;6(1):60-67

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