Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation
This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).
• Aged between 18 and 75 years (inclusive).
• Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).
• Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.
• Tumor tissue testing confirms KRAS G12D mutation.
• No prior systemic anti-tumor therapy.
• At least one evaluable lesion according to RECIST v1.1 criteria.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
• Expected survival time ≥ 3 months.
• Adequate organ function meeting the following requirements (no use of any blood components or colony-stimulating factors within 2 weeks prior to enrollment):
‣ Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
⁃ Platelets ≥ 80 × 10⁹/L
⁃ Hemoglobin ≥ 100 g/L
⁃ Serum albumin ≥ 30 g/L
⁃ Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN
⁃ Creatinine clearance ≥ 50 mL/min or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3)
⁃ Electrocardiogram: QTcF ≤ 450 ms (male), QTcF ≤ 470 ms (female)
⁃ Cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) ≥ 50%
• Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment, must be non-lactating, and must be willing to use adequate contraception during the trial and for 6 months after the end of treatment. For men, they must be surgically sterile or agree to use adequate contraception during the study and for 6 months after the end of treatment.
• Voluntary participation in this study and signing of informed consent, good compliance, and agreement to cooperate with follow-up.