Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Phase 3

• Conditions: Cholangiocarcinoma
• Interventions: Drug: oxaliplatin and gemcitabine; Drug: capecitabine

• Registration Number: NCT02548195
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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).

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-07
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 286

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEMOX	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.
Capecitabine	capecitabine	capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	from the date of surgery to the date of tumor recurrence up to 36 months after surgery

Secondary Outcome Measures

Name	Time	Method
Overall survival	from the date of surgery to the date of death up to 36 months after surgery

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China