EUCTR2014-004619-36-BE进行中（未招募）1 期
A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy - EPOCH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients must meet all of the following inclusion criteria:
- •1. Must be a male or female, 18 years of age or older, and of any ethnic or racial group
- •2. If primary tumor has not been resected, it must be clinically stable
- •3. Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy
- •4. Must be eligible to receive second-line standard-of-care chemotherapy with either
- •1) an oxaliplatin-based chemotherapy regimen, or
- •2) an irinotecan-based chemotherapy regimen
- •5. Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
- •6. Tumor replacement <50% of total liver volume
- •7. Current ECOG Performance Status score of 0-1 through screening to first treatment on study.
- •8. Will have completed the first line chemotherapy regimen at least 14 days prior to the initiation of 2nd line chemotherapy under the protocol
- •9. Patient is willing to participate in the study and has signed the study informed consent.
- •10. Serum creatinine <2.0 mg/dL
- •11. Serum bilirubin up to 1.2 x upper limit of normal
- •12. Albumin >3.0 g/dL
- •13. Must not have a history of hepatic encephalopathy
- •14. Must not have any contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g. closure device)
- •15. No history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
- •16. Must have neutrophil count >1200/mm3 (1.2x109/L)
- •17. No presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
- •18. No cirrhosis or portal hypertension
- •19. Must not have received prior external beam radiation treatment to the liver
- •20. Must not have received any prior intra-arterial liver directed therapy, including TACE, or Y-90 microsphere therapy
- •21. Must not have any planned liver directed therapy or radiation therapy
- •22. Must not have planned treatment with biological agents within 28 days prior to receiving TheraSphere
- •23. Must not have undergone any intervention for, or compromise of, the Ampulla of Vater
- •24. Must not have any clinically evident ascites (trace ascites on imaging is acceptable)
- •25. Must not have any toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient
- •26. Must not have any significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including
排除标准
- •No exclusion criteria listed
研究者
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