Advanced Cancer, Metastatic Cancer, Pancreatic Cancer
Conditions
Brief summary
The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in advanced or metastatic pancreatic cancer. The main questions it aims to answer are: * prognostic value of baseline MRD; * the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before first-line chemotherapy initiation and at the first imaging assessment after chemotherapy.
Interventions
Another chemotherapy regimen, targeted therapy, or immunotherapy
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer; * both sexes, age ≥18 years old; * ECOG performance status score ≤2; * the expected survival time was ≥3 months.
Exclusion criteria
* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma; * treated with any systemic antitumor treatment before first-line chemotherapy onset; * died or lost to follow-up within one month after the initiation of first-line chemotherpay; * combined with other primary malignances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline until death from any cause (up to approximately 24 months) | The date of first-line chemotherpay initiation to tumor progression or death due to any cause in the absence of progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Baseline until death from any cause (up to approximately 24 months) | The date of first-line chemotherpay initiation to death due to any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The prognostic value of MRD | Baseline until death from any cause (up to approximately 24 months) | The prognostic value of baseline MRD and dynamic MRD changes |
| The prognostic role of targeted therapy selected based on MRD | Baseline until death from any cause (up to approximately 24 months) | The prognostic role of targeted therapy selected based on MRD |
Countries
China
Contacts
Primary ContactChunmei Bai, MD
Backup ContactHui Tang, MD
Outcome results
None listed