HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.
Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.
2. Acute or chronic pancreatitis requiring clinical intervention.
Trial design
Treatments tested in this trial
- HRS-4642+AG+Nimotuzumab
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov