Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma

To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Inclusion Criteria:

• ECOG PS≤1;
• pathologically confirmed adenocarcinoma of bile duct;
• R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size >5 cm, preoperative CA199>200 U/mL.
• postoperative liver function Child Pugh Class A, leukocyte count>1.5*10^9/L, platelet count>100*10^9/L, serum alanine aminotransferase <1.5*ULN
• no tumor recurrence or metastasis on baseline examination
• no history of radiotherapy or intervention therapy

Exclusion Criteria:

• hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
• distant metastasis
• prothrombin time >14s
• severe cardiopulmonary dysfunction
• severe renal dysfunction
• bone marrow suppression before the initiation of therapy
• allergic to fluorouracil, gemcitabine, or platinum
• gemcitabine was used in combination with radiotherapy