HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer
NCT ID: NCT05751850
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
778 participants
INTERVENTIONAL
2023-06-13
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel; gemcitabine
nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine
Interventions
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HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HR070803-301
Identifier Type: -
Identifier Source: org_study_id
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