Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Conditions
Brief 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.
Interventions
Irinotecan liposome、5-Fluorouracil、Leucovorin
DRUGPlacebo、5-Fluorouracil、Leucovorin
Placebo、5-Fluorouracil、Leucovorin
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | The maximum time in follow up was approximately 12 months | OS is defined as the time from randomization to death due to any cause, or censored at date last known alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | The maximum time in follow up was 12 months | 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. |
| Objective Response Rate | Assessment every 6 weeks after initial response; maximum time on study 12 months | Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Time to Treatment Failure | The maximum time in follow up was 12 months | Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death. |
| Percentage of Patients With Tumor Marker (CA 19-9) Response | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months | Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period. |
| Quality of life（QoL） | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months | QoL was based on EORTC-QLQ-C30 |
Countries
China
Outcome results
None listed