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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT03026803
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed hepatocellular carcinoma which is recurrent, metastatic or unresectable.
* Patients may have up to two prior chemotherapy regimes. In addition, they may have had previous radiation, chemoembolization, and/or alcohol injections.
* Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly progressed during the observation interval prior to participation in this study. Pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s).
* Karnofsky performance status \> 70%.
* Patients should have an expected survival of at least 2 months.
* Leukocytes \>3,000/µl
* Absolute neutrophil count \>1,500/µl
* Platelets \>50,000/µl
* Total bilirubin \< 3.0 g/dl
* AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) \< 5 times institutional upper limit of normal
* Creatinine \< 2.0 OR measured or calculated creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal
* Brain metastasis is not an exclusion, however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or stereotactic RT.
* Patients with no evidence of clinically significant neuropathy.
* All prior therapy must have been completed at least 4 weeks prior to the patient's entry on this trial.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Breastfeeding should be discontinued if the mother is treated with oxaliplatin.
* Subjects with chronic hepatitis B or C may be undergoing treatment with α interferon and/or ribavirin, as long as they meet the other criteria for entry on to this study.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other investigational agents.
* History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
* HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
* Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.
* Patients unable to swallow capecitabine will be excluded from this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03026803
Study Brief:
Protocol Section:
NCT03026803