Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT02548195
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02548195
Study Brief:
Protocol Section:
NCT02548195