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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT07099794
Eligibility Criteria:
Inclusion Criteria:
* The patients voluntarily joined the study and signed the informed consent;
* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
* Previous first-line combination therapy failed;
* At least one measurable lesion meets the RECIST v1.1 criteria
* ECOG PS：0\~1；
* Expected survival ≥12 weeks;
* Essential organ and hematological function;
* Patients need contraception;
Exclusion Criteria:
* The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
* Patients had active malignancies other than BTC within 5 years or at the same time.
* Clinical symptoms or diseases of the heart that are not well controlled;
* Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
* Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \> grade 2;
* A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;
* Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent;
* Known allergy to the study drug;
* An uncontrolled infection occurs during screening;
* Patients with congenital or acquired immune deficiency (e.g., HIV);
* Have a history of brain metastases or have developed brain metastases;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07099794
Study Brief:
Protocol Section:
NCT07099794