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

NCT05047991 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-09-17

No results posted yet for this study

Summary

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.

Conditions

  • Pancreatic Cancer Non-resectable
  • Pancreatic Cancer Metastatic

Interventions

DRUG

Irinotecan Liposome Injection

Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle

DRUG

Fluorouracil

5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle

DRUG

Leucovorin

Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle

DRUG

Oxaliplatin

Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle

DRUG

Nab paclitaxel

Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

DRUG

Gemcitabine

Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-11-30
Completion
2024-11-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047991 on ClinicalTrials.gov