Next-Generation Sequencing via Tissue and Liquid Biopsy in Patients with Metastatic Pancreatic, Biliary, and Colorectal Cancers: Correlation with Therapeutic Response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Objective Response Rate (ORR)
研究概览
简要总结
Pancreatic and Biliary tract and colorectal cancers represents a group of gastrointestinal malignancies with distinct etiologies but share common challenges in metastatic settings limited treatment options and modest survival outcomes and last stage diagnosis and Pancreatic Ductal Adenocarcinoma and Biliary tract cancers typically present at advanced stage with median overall survival rarely exceeding 12 months even with combination of chemotherapy regime then in this study we want to learn about genetic changes in patients with these type of cancers and we will do it by analysing samples from tumour tissue and blood samples using methods called Next Generation Sequencing and This research may help us to understand how certain gene changes affect how will patients respond to the cancer treatments and Purpose of the studies to find out certain genetic changes in cancers patients can predict how well they will respond to the and see if simple blood test mean liquid biopsy gives similar results to a tissue biopsy Furthermore to check if regular blood test during treatment can help us to see the cancer is responding and if it is becoming resistant to the treatment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Histologically confirmed metastatic pancreatic, biliary, or colorectal cancer Planned systemic therapy Availability of archival or newly obtained tumor tissue Willingness to undergo serial blood draws ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2 Written informed consent provided.
排除标准
- •Exclusion Criteria: Inability to comply with study procedures.
- •Individual who, in opinion of the investigator, may not be able to adhere to the required study protocol or follow-up schedule will excluded.
- •Presence of a concurrent active malignancy requiring systemic therapy.
结局指标
主要结局
1. Objective Response Rate (ORR)
时间窗: First response assessment at ~8 weeks after treatment initiation, then every 8–12 weeks.
Definition: Proportion of patients achieving either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 criteria on serial imaging.
时间窗: First response assessment at ~8 weeks after treatment initiation, then every 8–12 weeks.
次要结局
- Progression-Free Survival (PFS)
- Concordance Rate Between Tissue and Liquid Biopsy NGS(The proportion of overlapping mutations (e.g., KRAS, TP53, BRAF) identified in both tissue and ctDNA samples at baseline, using Cohen’s kappa to assess agreement.)
- Overall Survival (OS)
- ctDNA Response(Every 2–3 treatment cycles (~6–8 weeks).)
- Molecular Progression via ctDNA(During follow-up blood draws every 2 cycles)
- Resistance Mutation Detection
研究者
Dr Alok K Goel
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
