Pancreatic Cancer
Conditions
Brief summary
To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
Interventions
DRUGHRS-4642+NALIRIFOX
HRS-4642+NALIRIFOX
DRUGHRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+Adebrelimab
Sponsors
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female participants aged 18-70 (including those who are 18 and 70 years old)； 2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 3. Life expectancy ≥ 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5. Adequate marrow and organ function;
Exclusion criteria
1. Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy; 2. Presence of distant metastatic lesions confirmed by imaging; 3. Known hypersensitivity to the investigational drug or any of its excipients; 4. Presence of any serious or uncontrolled systemic disease; 5. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Clinically significant acute or chronic pancreatitis; 7. Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment; 8. Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug; 9. Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose |
| Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) | Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response Rate (pCR) | At the time of surgery |
| R0 (microscopically margin-negative) resection rate | At the time of surgery |
| Major Pathologic Response Rate (MPR) | At the time of surgery |
Outcome results
None listed