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

Jiangsu HengRui Medicine Co., Ltd.298 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

298

Conditions

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

Interventions

Irinotecan liposome、5-Fluorouracil、LeucovorinDRUG

Irinotecan liposome、5-Fluorouracil、Leucovorin

Placebo、5-Fluorouracil、LeucovorinDRUG

Placebo、5-Fluorouracil、Leucovorin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Overall Survival(OS)

OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.

Time frame: The maximum time in follow up was approximately 12 months

Secondary Outcomes

Progression Free Survival

Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first.

Time frame: The maximum time in follow up was 12 months

Objective Response Rate

Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time frame: Assessment every 6 weeks after initial response; maximum time on study 12 months

Time to Treatment Failure

Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.

Time frame: The maximum time in follow up was 12 months

Percentage of Patients With Tumor Marker (CA 19-9) Response

Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.

Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months

Quality of life（QoL）

QoL was based on EORTC-QLQ-C30

Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months

Data from ClinicalTrials.gov

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