Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2022-04-23
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed pancreatic cancer;

2. Unresectable locally advanced or metastatic disease ;

3. Documented disease progression after first-line treatment gemcitabine based therapy

4. ECOG: 0-1;

5. Adequate organ and bone marrow function;

6. sign an informed consent.

Exclusion Criteria:

1. Active CNS metastasis;

2. Uncontrolled tumor-related pain;

3. Clinically significant GI disorders;

4. Significant cardiovascular disease;

5. Active infection or uncontrolled fever;

6. Pregnant or breast feeding patients;

7. Allergic to a drug ingredient or component;

8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.