Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Nil: Nil
Intervention6: Nil: Nil
Intervention7: Nil: Nil
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Objective Response Rate (ORR) Definition: Proportion of patients achieving either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 criteria on serial imaging. Timepoint: First response assessment at ~8 weeks after treatment initiation, then every 8 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) Timepoint: Time from initiation of systemic therapy to documented radiologic or clinical disease progression or death from any cause. Based on RECIST v1.1 & clinical judgment;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. Timepoint: At baseline Before treatment;Overall Survival (OS) Timepoint: Time from initiation of systemic therapy to death from any cause. ;ctDNA ResponseTimepoint: Every 2 3 treatment cycles (~6 8 weeks).;Molecular Progression via ctDNATimepoint: During follow-up blood draws every 2 cycles;Resistance Mutation Detection Definition: Identification of known resistance mutationsTimepoint: till progression | — |
Countries
India
Contacts
Public ContactDr Alok K Goel
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
Outcome results
None listed