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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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First-line Treatment of Advanced Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

Group Type EXPERIMENTAL

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

Intervention Type DRUG

HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate

nab-paclitaxel; gemcitabine

Group Type ACTIVE_COMPARATOR

nab-paclitaxel; gemcitabine

Intervention Type DRUG

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

Intervention Type DRUG

nab-paclitaxel; gemcitabine

nab-paclitaxel in combination with gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Zhang

Role: CONTACT

0518-82342973

Other Identifiers

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HR070803-301

Identifier Type: -

Identifier Source: org_study_id

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