A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer

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.

NCT Number	NCT07438106
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Locally Advanced Pancreatic Cancer With KRAS G12D Mutation
Enrollment	30 participants
Start Date	2026-01-28
Primary Completion	2027-10 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-12