A Phase III Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer
Trial Parameters
Brief Summary
This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer. Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination. After the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for this study: 1. Age ≥18 years and ≤75 years, regardless of gender. 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. 3. Radiologically confirmed locally advanced disease, defined as: 1. No distant metastasis. 2. Pancreatic head/uncinate process tumors: Tumor contact with the superior mesenteric artery (SMA) \>180°. 3. Pancreatic body/tail tumors: Tumor contact with the SMA or celiac artery \>180°; or contact with the celiac artery with aortic invasion; or tumor invasion of the jejunal branches of the SMA. 4. Inability to safely reconstruct the portal vein-superior mesenteric vein due to tumor invasion, venous occlusion, or extensive involvement of the jejunal branches of the superior mesenteric vein. 4. KRAS G12D mutation confirmed by tissue histology or peripheral blood testing. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. No pr