This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.
Neutrophil count≥1.5×10^9 / L;
Platelet≥100×10^9 / L;
Hemoglobin≥100 g / L;
Serum albumin≥30 g / L;
Previous treatment of targeted therapy against KRAS G12D.
Previous targeted therapy against EGFR.
Received major surgery or major trauma within 4 weeks before enrollment, or palliative local treatment (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.
Have received any other clinical study medication within 4 weeks before enrollment, except for an observational (non-interventional) clinical study or interventional clinical study follow-up.
Parallel
HRS-4642
DrugHRS-4642 is a KRAS G12D inhibitor
Nimotuzumab
DrugNimotuzumab is a humanized IgG 1 monoclonal antibody targeting EGFR
gemcitabine + nab-paclitaxel
DrugAlbumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks
Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study
Duration of remission （DoR）
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during the whole study.
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Progression-free survival （PFS）
The time from enrolled to disease pregression or death from any cause during the whole study.
Overall survival (OS)
The time from enrolled to death from any cause during the whole study.
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