Overview

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