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Trial Title:
HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer
NCT ID:
NCT05751850
Condition:
First-line Treatment of Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Leucovorin
Paclitaxel
Gemcitabine
Oxaliplatin
Fluorouracil
Calcium
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Description:
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
Arm group label:
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Intervention type:
Drug
Intervention name:
nab-paclitaxel; gemcitabine
Description:
nab-paclitaxel in combination with gemcitabine
Arm group label:
nab-paclitaxel; gemcitabine
Summary:
The purpose of this study is to look at the efficacy and safety of HR070803 in
combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to
nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not
previously treated for metastatic pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ECOG performance status 0 or 1
2. Histological or cytologically confirmed pancreatic cancer that has not been
previously treated in the metastatic disease.
3. Life expectancy of greater than or equal to3 months.
4. At least one measurable lesion is present according to the efficacy evaluation
criteria for pancreatic cancer (RECIST 1.1)
5. Able and willing to provide a written informed consent
Exclusion Criteria:
1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium,
including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the
pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Known history of central nervous system (CNS) metastases.
3. Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection
complications, etc. requiring inpatient treatment, occurred within four weeks before
enrollment, and symptoms and signs of infection requiring intravenous antibiotic
therapy (except for prophylactic antibiotics) occurred within two weeks before
enrollment;
4. Patients with cardiac clinical symptoms or diseases that are not well controlled,
such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable
angina; (3) myocardial infarction that occurred within 6 months; (4) clinically
significant supraventricular or ventricular arrhythmia requiring treatment or
intervention.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Investigator:
Last name:
Yupei Zhao
Email:
Principal Investigator
Investigator:
Last name:
Wenming Wu
Email:
Principal Investigator
Start date:
June 13, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751850
