Cholangiocarcinoma
Conditions
Keywords
GEMOX, intrahepatic cholangiocarcinoma, adjuvant therapy, oxaliplatin, gemcitabine, capecitabine, curative surgery
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).
Interventions
DRUGoxaliplatin 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.
DRUGcapecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | from the date of surgery to the date of tumor recurrence up to 36 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | from the date of surgery to the date of death up to 36 months after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events and severe adverse events | from the date of first dosage to safety follow-up visit (30 days after the last dosage) | All toxicities will be graded by CTCAE v4 |
Countries
China
Contacts
Primary ContactHui-Chuan Sun, MD, PhD
Backup ContactMei-Ling Li
Outcome results
None listed