HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer

NCT06217042 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HR070803-307
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief 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 gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.

  From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment)

Secondary Outcomes (5)

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 37 months

• 3-year disease-free survival rate

  up to 36 months following the date the first patient was randomized

• 5-year disease-free survival rate

  up to 60 months following the date the first patient was randomized

• 3-year overall survival rate

  up to 36 months following the date the first patient was randomized

• 5-year overall survival rate

  up to 60 months following the date the first patient was randomized

Study Arms (2)

HR070803+Oxaliplatin+5-FU/LV

EXPERIMENTAL

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

GX

ACTIVE COMPARATOR

gemcitabine; capecitabine

Drug: gemcitabine; capecitabine

Interventions

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate DRUG

Oxaliplatin 85 mg/m² D1 over 2 hours, followed by HR070803 60 mg/m² D1 over 90 minutes, after the Folinic acid infusion is started. Folinic acid 400 mg/m² D1, IV infusion over 1 hours. 5-FU 2400 mg/m² D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 12 cycles, 24 weeks.

HR070803+Oxaliplatin+5-FU/LV

gemcitabine; capecitabine DRUG

Gemcitabine 1000mg/m² is given as an i.v. infusion over 30 minutes, administered on day 1, 8 and 15 out of 28 days. Capecitabine 1660mg/m²/day in two divided doses administered orally for 21 days followed by 7 days'rest .

GX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0 or 1
• Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
• Life expectancy of greater than or equal to 6 months.
• Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
• Acceptable hematology parameters and blood chemistry levels.
• Able and willing to provide a written informed consent.

You may not qualify if:

• Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
• Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
• CA 19-9\> 180 U / ml within 21 days of registration on study.
• Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Si Shi, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Si Shi, PhD

CONTACT

+86 18917266285; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Ending of trials, preserved for 10 years.
• Access Criteria: Researchers within pancreatic cancer field.

Locations

CN (1)