Comprehensive Genomic Profiling of Hepatocellular Carcinoma Assessing Genetic Alterations and Tumor Evolution Following Immunotherapy in Biopsy-Proven Patients PROGEN HCC study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess genomic alterations in biopsy-proven hepatocellular carcinoma (HCC) patients at baseline and after 3 doses of immunotherapy with Atezolizumab and Bevacizumab.
研究概览
简要总结
Patients with BCLC stage C or stage B hepatocellular carcinoma (HCC),will be recruited for the study. Informed consent will be obtained following a detailed explanation of the study, and baseline clinical data will be recorded.
Blood samples will be collected from each patient, with three tubes of 10 ml each. One BD K2 EDTA tube will be used for the analysis of circulating tumor cells (CTCs), while two PAXGENE® tubes will be used for circulating tumor DNA (ctDNA) analysis. These samples will provide important insights into the genetic changes in tumors without the need for invasive procedures.
The OncoDiscover® Liquid Biopsy test will be used to detect CTCs, which are indicative of cancer progression. Meanwhile, Oncolndx® NGS profiling will offer a comprehensive genomic analysis, covering over 1000 genes, including key actionable mutations, resistance markers, homologous recombination deficiency (HRD) scores, and immunotherapy markers such as tumor mutational burden (TMB) and microsatellite instability (MSI).
Blood samples will be transported to OneCell Diagnostics, Pune, for CTC enumeration and ctDNA testing using the OncoRADAR assay. This assay allows for the isolation and profiling of single CTCs, providing detailed insights into tumor heterogeneity and metastatic potential.
The genomic data generated from liquid biopsies, alongside traditional tissue biopsies, will be analyzed to assess their correlation with treatment response, disease progression, and clinical outcomes. This dual approach will provide a comprehensive understanding of how immunotherapy influences HCC at both the cellular and molecular levels.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults greater than or equal to 18 years diagnosed with biopsy proven advanced or unresectable HCC.
- •2 Patients with BCLC stage C or BCLC stage B 3 Treatment naïve for systemic therapy.
- •4 Child Pugh A or B, ECOG lesser than or equal to 2 5 Signed informed consent.
排除标准
- •1 Prior liver transplant.
- •2 Previous systemic therapy for HCC.
- •3 Significant comorbidities or active infections 4 High risk esophageal or gastric varices.
结局指标
主要结局
To assess genomic alterations in biopsy-proven hepatocellular carcinoma (HCC) patients at baseline and after 3 doses of immunotherapy with Atezolizumab and Bevacizumab.
时间窗: Baseline and 12 weeks
次要结局
- • To evaluate the relationship between key genomic alterations e.g., CTNNB1, TERT, TP53 & immune phenotypes hot vs. cold following immunotherapy.(•To explore the association between genomic changes & clinical response, including tumour mutation burden TMB & immune cell infiltration.)
研究者
Sonal Asthana
Aster CMI Hospital