JPRN-jRCTs031190236
Completed
Phase 2
Single arm study to evaluate the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma patients in Japanese real-world practice; focusing on the completion of the REACH-2 study
Ogasawara Sadahisa0 sites30 target enrollmentMarch 3, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chemotherapy
- Sponsor
- Ogasawara Sadahisa
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who meet all of the following criteria will be included:
- •1\)Patients must have been diagnosed with HCC by either of the following assessments:
- •a)Histological or cytological diagnosis of HCC
- •b)Radiographic image diagnosis of HCC by the typical findings on dynamic CT, CTHA/CTAP, dymamic MRI.
- •2\)Patients must meet all of the following criteria on treatment of HCC:
- •a)Not applicable for surgical resection.
- •b)Not applicable for any local therapies (radio frequency ablation, percutaneous ethanol injection, microwave ablation).
- •c)Not applicable for transarterial chemoembolization (TACE).
- •3\)ECOG Performance Status (PS) of 0 or 1\.
- •4\)Patients with Child\-Pugh class A
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from the study.
- •1\)Patients with a history of malignant tumors except for the following cases.
- •a)Early\-stage cancers with a low risk of relapse after appropriate radical treatment such as intraepithelial cervical cancer, basal cell carcinoma, superficial bladder tumor \[Ta, Tis and T1] and early gastric cancer.
- •b)Malignant tumors that have been given radical treatment at least three years before enrollment and is considered to have not relapsed since then.
- •2\)Patients on kidney dialysis.
- •3\)Heart disease which falls into any of the following categories.
- •a)Heart failure of NYHA class 2 or higher.
- •b)Coronary artery disease with symptoms. History of myocardial infarction within 24 weeks prior to enrollment.
- •c)Arrhythmias that is uncontrolled by the treatment of antiarrhythmic drugs such as beta blocker and digoxin (CTCAE version 4\.0 Grade 3 or higher).
- •d)Poorly controlled hypertension.
Outcomes
Primary Outcomes
Not specified
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