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Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer

NCT05795920 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-04-03

No results posted yet for this study

Summary

This trial is an efficacy and safety evaluation of the use of Utidelone injection in combination with gemcitabine for inoperable and locally inappropriate use first-line chemotherapy in the treatment of advanced pancreatic cancer.

Main Purpose:To evaluate the use of utidelone in combination with gemcitabine in unresectable, advanced pancreatic cancer without progressionSurvival (PFS), overall survival (OS), duration of response (DOR), and safety; Secondary objective: Use of utidelone in combination with gemcitabine in patients with unresectable, advanced pancreatic cancer, according to investigators Objective response rates (ORRs) assessed against RECIST v1.1 criteria.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

Utidelone injection in combination with gemcitabine

Utidelone injection: 30mg/m2, for days 1-5, once a day, 21 days for a treatment week Period; Gemcitabine: 1000mg/m2, Q3W on day 1 and day 8, 21 days for a treatment cycle

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xueying Ding, Prof. · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2024-07-08
Completion
2025-09-08

Countries

  • China

Study Locations

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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 NCT05795920 on ClinicalTrials.gov