Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID
NCT05047991
Phase
PHASE2
Status
Unknown

Conditions

  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposome Injection — DRUG
    Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle
  • Fluorouracil — DRUG
    5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle
  • Leucovorin — DRUG
    Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle
  • Oxaliplatin — DRUG
    Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle
  • Nab paclitaxel — DRUG
    Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle
  • Gemcitabine — DRUG
    Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Study Details

This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. The purpose of this study is to evaluate the differences of safety and efficacy of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma.

Key Dates

Start date
Oct 31, 2021
Status verified
Sep 2021
Primary completion
Nov 30, 2023
Completion
Nov 30, 2024

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Irinotecan Liposome Injection + 5-FU/LV + Oxaliplatin
    The patients in cohort 1 will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin(LV) and oxaliplatin intravenously on day 1 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.
  • Active Comparator: Cohort 2: Nab-paclitaxel + Gemcitabine
    The patients in cohort 2 will receive nab-paclitaxel and gemcitabine intravenously on day 1、day 8 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to twelve months after the last patient's first administration ]

Central Contacts

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