About this trial
To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥18 years old, male or female;
Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Disqualifiers
Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine;
Known hypersensitivity to the study drug or any of its components;
Previous or concurrent other malignant tumors;
Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
Trial design
Parallel
Treatments tested in this trial
HRS-4642
DrugHRS-4642 in Combination with Immunotherapy and Chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Adverse events (AEs)
Arm 1:Objective Response Rate (ORR)
Arm 2:18m-OS rate
Overall survival (OS):The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Sponsors and contacts
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