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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT03345303
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
2. Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;
3. The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;
6. Normal liver,kidney and bone marrow function；
7. Subjects who understand and voluntarily signed a written informed consent form.
Exclusion Criteria:
1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis
2. There is any contraindication to use Bortezomib
3. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
4. A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
5. Pregnant or lactating women.
6. History of radiation within 4 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03345303
Study Brief:
Protocol Section:
NCT03345303