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Anti-metabolite

Cohort 1: Irinotecan Liposome Injection + 5-FU/LV + Oxaliplatin for Pancreatic Cancer

Phase 2

Waitlist Available

Research Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to twelve months after the last patient's first administration

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 days before the first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 days before the first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 days before the first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Area under the plasma concentration versus time curve

Disease Control Rate (DCR)

Duration of Response (DOR)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 1: Irinotecan Liposome Injection + 5-FU/LV + OxaliplatinExperimental Treatment4 Interventions

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.

Group II: Cohort 2: Nab-paclitaxel + GemcitabineActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

FDA approved

Fluorouracil

FDA approved

Oxaliplatin

FDA approved

Irinotecan

FDA approved