HUTCHMED has initiated the phase-III part of the phase-II/III trial to evaluate the efficacy of the combination of surufatinib, camrelizumab nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in China. The first patient received the first dose on 30 December, 2025.

The trial is a multicentre, randomised, open-label, active-controlled phase-II/III study to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel and gemcitabine (S+C+AG) versus nab-paclitaxel plus gemcitabine (AG) in adults with metastatic pancreatic cancer who have not previously received systemic anti-tumour therapy.

A total of 62 patients were enrolled in the phase-II part, with plans to enroll approximately 400 additional patients in the phase-III part. The primary endpoint for the phase-III part is Overall Survival (OS). Secondary endpoints include Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), Disease Control Rate (DCR), quality of life and safety.

Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital are the leading principal investigators of this study.

Results from the phase-II part were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress. As of the data cut-off of July 24, 2025, the median PFS follow-up duration was 8.15 months. The S+C+AG regimen demonstrated a median PFS of 7.20 months compared to 5.52 months for the AG arm (stratified hazard ratio [HR] 0.499, log-rank p=0.0407), representing a 50.1 percent reduction in the risk of progression or death.