NCT02548195

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	oxaliplatin and gemcitabine	oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.
DRUG	capecitabine	capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-09-14
• Last updated: 2015-09-14

Locations

1 site across 1 country: China