Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

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

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

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Drug: oxaliplatin and gemcitabine
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEMOX<br>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: oxaliplatin and gemcitabine<br>* 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.<br>* Other names: gemcitabine;|
| Active Comparator: Capecitabine<br>capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total. | Drug: capecitabine<br>* capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  | from the date of surgery to the date of tumor recurrence up to 36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | from the date of surgery to the date of death up to 36 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GEMOX, intrahepatic cholangiocarcinoma, adjuvant therapy, oxaliplatin, gemcitabine, capecitabine, curative surgery