Locally Advanced, 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 borderline resectable or locally advanced 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 conversion therapy 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 borderline resectable or locally advanced pancreatic cancer; * conversion therapy was planned; * 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 |
|---|---|---|
| Resection rate | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) | Proportion of patients who receive surgical resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Baseline until PD or death, whichever occurs first (up to approximately 24 months) | The date of conversion therapy initiation to death due to any cause. |
| Progression-free survival | Baseline until PD or death, whichever occurs first (up to approximately 24 months) | The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression. |
| R0 resection rate | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) | Proportion of patients who receive R0 surgical resection |
| Major pathological response | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) | ≤10% of the viable tumor cell in resected sample |
Other
| Measure | Time frame | Description |
|---|---|---|
| The prognostic value of MRD | Baseline until PD or death, whichever occurs first (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 PD or death, whichever occurs first (up to approximately 24 months) | The prognostic role of targeted therapy selected based on MRD |
Countries
China
Contacts
Primary ContactChunmei Bai, MD
Outcome results
None listed