Last updated: May 8, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Digestive System Neoplasms
Treatment
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
nab-paclitaxel; gemcitabine
Clinical Study ID
NCT05751850
HR070803-301
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ECOG performance status 0 or 1
- Histological or cytologically confirmed pancreatic cancer that has not been previouslytreated in the metastatic disease.
- Life expectancy of greater than or equal to3 months.
- At least one measurable lesion is present according to the efficacy evaluationcriteria for pancreatic cancer (RECIST 1.1)
- Able and willing to provide a written informed consent
Exclusion
Exclusion Criteria:
- Patients with pancreatic cancer originating from extrapancreatic ductal epithelium,including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas,pancreatoblastoma, and solid-pseudopapillary tumor;
- Known history of central nervous system (CNS) metastases.
- Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infectioncomplications, etc. requiring inpatient treatment, occurred within four weeks beforeenrollment, and symptoms and signs of infection requiring intravenous antibiotictherapy (except for prophylactic antibiotics) occurred within two weeks beforeenrollment;
- Patients with cardiac clinical symptoms or diseases that are not well controlled, suchas: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3)myocardial infarction that occurred within 6 months; (4) clinically significantsupraventricular or ventricular arrhythmia requiring treatment or intervention.
Study Design
Total Participants: 778
Treatment Group(s): 2
Primary Treatment: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Phase: 3
Study Start date:
June 13, 2023
Estimated Completion Date:
December 30, 2025
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
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