MedTrace Logo

Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer

NCT06513455 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-07-22

No results posted yet for this study

Summary

This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.

The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .

This study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.

Conditions

Interventions

DRUG

Irinotecan liposome（40mg/m2）

irinotecan Liposome was administered 40mg/m2, D1，iv. q2w

DRUG

Nab-paclitaxel

Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w

DRUG

Gemcitabine

gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w

DRUG

Irinotecan Liposome（60mg/m2）

irinotecan Liposome was administered 60mg/m2, D1，iv. q2w

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Yanqiao Zhang, Zhang · Harbin Medical University Cancer Hosptital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-06-30
Completion
2027-12-31

More Related Trials

Entities

Drugs
Diseases

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 NCT06513455 on ClinicalTrials.gov