View clinical trials related to Liver, Cancer of, Non-Resectable.
Filter by:This is a Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma (HCC) and other solid tumor types known for association with the MYC oncogene. The study consists of Part 1 (OTX-2002 monotherapy) and Part 2 (OTX-2002 combined with standard of care in hepatocellular carcinoma). Part 1 consists of escalation and expansion, and Part 2 consists of safety run-in and expansion. The objective of Part 1 escalation and Part 2 safety run-in will be safety and tolerability, while anti-tumor activity will be evaluated as the primary endpoint in Part 1 and Part 2 expansion.
Protocol Synopsis Title A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia Supplier BTG International Canada Inc. Type of Clinical Use Post-Marketing: TheraSphere® commercially distributed under HDE # 980006 Objectives • Provide supervised access to TheraSphere® therapy at this institution - Evaluate response to treatment - Evaluate toxicities and adverse experiences associated with TheraSphere® treatment - Evaluate survival time Number of Patients Up to 100 patients per year, expandable following completion of the first cohort. Patients will be excluded: if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk. Required Lab Parameters AST or ALT <5 times ULN For HCC: Bilirubin ≤ 2.0 mg/dl (unless segmental infusion is used) Negative pregnancy test in premenopausal women For other primary or secondary liver neoplasia, bilirubin levels specific to the primary or secondary liver neoplasia will be determined to confirm suitability for TheraSphere® treatment Negative pregnancy test in premenopausal women Endpoints Provide TheraSphere® for patients who it is determined by their treating physicians and/or tumor board that the device is appropriate for the treatment of unresectable HCC in accordance with the FDA recommendation of use of a HUD within its approved indication or for the treatment of the patient's other primary or secondary liver neoplasia and is in accordance with the FDA recommendation of use of a HUD outside of its approved indication. Evaluate SAE's associated with TheraSphere® treatment. TheraSphere® Treatment: Suggested Table of Time and Events. TIME Pre-Treatment Evaluation First Treatment First Follow-up Visit Second Treatment3 Post-Treatment Follow-up3 EVENTS -30 to -5 Days Day 0 Day 21 - 42 Day 30 - 90 3 months - 24 months
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.