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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

Treatments: Drug: Placebo、5-Fluorouracil、Leucovorin; Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05074589

HR-IRI-APC

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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298 participants in 2 patient groups

Treatment group A

Experimental group

Description:

Irinotecan liposome plus 5-fluorouracil, Leucovorin

Treatment:

Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin

Treatment group B

Active Comparator group

Description:

Placebo plus 5-fluorouracil, Leucovorin

Treatment:

Drug: Placebo、5-Fluorouracil、Leucovorin