Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Fudan University

Status and phase

Unknown

Phase 3

Conditions

Cholangiocarcinoma

Treatments

Drug: capecitabine

Drug: oxaliplatin and gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02548195

gemoxicc

Details and patient eligibility

About

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.

Full description

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

Enrollment

286 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

286 participants in 2 patient groups

GEMOX

Experimental group

Description:

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.

Treatment:

Drug: oxaliplatin and gemcitabine

Capecitabine

Active Comparator group

Description:

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

Treatment:

Drug: capecitabine