Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD-guided | Experimental | Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy. |
|
| Routine treatment | No Intervention | Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Later-line therapy | Drug | Another chemotherapy regimen, targeted therapy, or immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate | Proportion of patients who receive surgical resection | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The date of conversion therapy initiation to death due to any cause. | Baseline until PD or death, whichever occurs first (up to approximately 24 months) |
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| The prognostic value of MRD | The prognostic value of baseline MRD and dynamic MRD changes | Baseline until PD or death, whichever occurs first (up to approximately 24 months) |
| The prognostic role of targeted therapy selected based on MRD |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunmei Bai, MD | Contact | 010-69158764 | +86 | tangh160706@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunmei Bai, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.
| Baseline until PD or death, whichever occurs first (up to approximately 24 months) |
| R0 resection rate | Proportion of patients who receive R0 surgical resection | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) |
| Major pathological response | ≤10% of the viable tumor cell in resected sample | Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months) |
The prognostic role of targeted therapy selected based on MRD
| Baseline until PD or death, whichever occurs first (up to approximately 24 months) |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |