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NICRRBTCNCT06699459

Irinotecan Liposomes +5-FU/LV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

one year DFS rate
Timeframe: From date of randomization until the date of one year

Secondary (4)

Progression free survival
Overall survival
Disease-free survival
adverse events

Arms and interventions

Irinotecan liposomeExperimental

* Irinotecan liposomes: 70mg/m2, intravenous infusion, Q2W, d1; ②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2;

CapecitabineOther

Capecitabine, 1250mg/m2 oral, bid, Q3W, d1-14;

Drugs: Irinotecan Liposome, Capecitabine

Sites

6 sites in 1 country