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

Pancreatic Cancer Clinical Trial

Official title:

HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217042
• Other study ID #: HR070803-307
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 5, 2024
• Est. completion date: July 30, 2028

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: Si Shi, PhD
• Phone: +86 18917266285
• Email: shisi[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. 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. Patients without event at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate.

Tolerance Patients evaluable for toxicity must have received one investigational drug.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 524
• Est. completion date: July 30, 2028
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. ECOG performance status 0 or 1

2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).

3. Life expectancy of greater than or equal to 6 months.

4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.

5. Acceptable hematology parameters and blood chemistry levels.

6. 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. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.

3. CA 19-9> 180 U / ml within 21 days of registration on study.

4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.

5. 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;

6. 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
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.
• gemcitabine; capecitabine
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 .

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	OS is defined as the time from date of randomization until the date of death from any cause.	From date of randomization until the date of death from any cause, assessed up to 37 months
Secondary	3-year disease-free survival rate	Disease-free survival within 3 years	up to 36 months following the date the first patient was randomized
Secondary	5-year disease-free survival rate	Disease-free survival within 5 years	up to 60 months following the date the first patient was randomized
Secondary	3-year overall survival rate	Overall survival within 3 years	up to 36 months following the date the first patient was randomized
Secondary	5-year overall survival rate	Overall survival within 5 years	up to 60 months following the date the first patient was randomized