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:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT03881306
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis is confirmed by biopsy or clinical data, primary site is resected or primary site is not resected but without risks of bleeding, obstruction in the near future.
* Failure of ≥ 1 system treatment, such as long-acting somatostatin or EP chemotherapy regimen.
* Standard surgical resection can not be performed because of extent liver involvement （liver involvement ≥ 2 lobes or ≥ 2 major vessels）, or patients who are not willing to accept surgical operation.
* Predicted survival \>3 months.
* Child Pugh Score: ≤ 7
* ECOG score for performance status: 0-1
* Informed consensus is achieved.
Exclusion Criteria:
* Metastases to other organs or sites besides liver.
* Prior TACE for liver tumors in 1 year.
* Obvious hepatic arterio-venous shunt or arterio-portal shunt.
* Prior or concurrent malignancy (Except basal carcinoma or squamous carcinoma of skin or carcinoma in situ of cervex uteri which has been cured).
* Platelet count \< 50,000/mm\^3 or white blood cell count \<3,000 /mm\^3 without hypersplenism.
* Creatinine greater than upper limit of normal (ULN)
* AST or AST \> 5 times ULN
* Compromised coagulation: INR (International normalised ratio) \>1.5, current anti-coagulation therapy or hemorrhagic disorders.
* History of severe diseases involving heart, kidney, marrow, lung or central neural system.
* Infection diseases which need antibiotics treatment before less than 1 month.
* Co-existing morbidity or social environment which may lead patients not to obey study protocol or threat patients' safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03881306
Study Brief:
Protocol Section:
NCT03881306