EUCTR2017-002755-29-NL进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation (CheckMate 9DX: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9DX) - CheckMate 9DX
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 883
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
- 性别
- All
入选标准
- •1. Males and females, ages 18 or older.
- •2. Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation.
- •3. Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
- •4. Participants are eligible to enroll if they have undergone:
- •i) Hepatic resection and have the following tumor characteristics: up to three tumors, at least one with a diameter > 5 cm OR none with a diameter > 5 cm but with confirmation of microvascular invasion or poorly /undifferentiated HCC; or more than three tumors, none with a diameter > 5 cm
- •ii) Local ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)] and have the following tumor characteristics: solitary tumor > 3cm but <=5 cm; OR Multiple tumors (up to 4), none with a diameter > 5 cm
- •5. Participants must have complete resection response, or must have achieved radiologically documented complete resection after local ablation.
- •6. All participants are required to have imaging studies confirming disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation, and within 4 weeks prior to randomization.
- •7. Child-Pugh Score 5 or 6
- •8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 441
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 442
排除标准
- •1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •2. Prior recurrence of HCC.
- •3. Any evidence of tumor metastasis or co-existing malignant disease.
- •4. Participants showing evidence of macrovascular invasion on imaging tests.
- •5. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
- •6. Active co-infection with with both Hepatitis B and C, OR Hepatitis D and B
- •7. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •8. Participants with an active, known or suspected autoimmune disease.
- •9. Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment.
- •10. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- •11. Participants previously receiving any prior therapy for HCC, including loco-regional therapies, before or after resection or ablation.
- •12. Participants receiving or expected to receive IFN-based therapies during the study period.
- •13. Positive pregnancy test.
研究者
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