Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Capecitabine; Gemcitabine; Oxaliplatin

Criteria

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