Communicative reprogramming non-curative hepatocellular carcinoma with low-dose metronomic chemotherapy, COX-2 inhibitor and PPAR-gamma agonist: a phase II trial.

摘要: Systemic therapy for advanced hepatocellular carcinoma (HCC) is still challenging. A biomodulatory approach targeting the communicative infrastructure of HCC, including metronomic low-dose chemotherapy with capecitabine, pioglitazone and rofecoxib, has been evaluated in patients non-curative HCC. Altogether 38 were evaluable this one-arm, multicenter phase II trial. The primary endpoint, median progression-free survival was 2.7 months (95% CI: 1.6–3.79) for all 8.4 months 0–18.13) ≥ 6 weeks on protocol. Median overall (OS) 6.7 months 4.08–9.31) 9.4 months 4.82–13.97), respectively. Most common adverse events edemas grade 3, which commonly related to stage, 66% suffering from liver cirrhosis. Exploratory data analyses showed significant impact ECOG performance status 0 versus 1 CLIP score 0/1 > 1 OS, 9.8 months 4.24–15.35) 1.03–4.36; P = 0.002), 3.23–16.37) 4.4 months 3.14–5.66; P = 0.009), Preceding tumor surgery had beneficial survival, as well maximal diameter < 5 cm. correlation C-reactive protein decrease significantly improved OS underlines close link between inflammation control. Biomodulatory HCC may be a low toxic, efficacious treatment principally demonstrates that such approaches should followed further