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

NCT05795920 | Unknown Phase 2 DMC

• 1 other identifier: UTD1-PC-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• overall survival

  Time from enrollment to death (from any cause)

  From date of randomization until the date of death from any cause assessed up to 100 months

• progression free survival progression free survival

  Disease progression from baseline assessment of enrollment to first radiographically verifiable disease progression (PD) (RECIST 1.1 standard) or deaths from any cause where progression was not recorded Time.

  From date of randomization until the date of first documented progression assessed up to 100 months

Secondary Outcomes (1)

• Duration of response Duration of Response

  Time from complete response/partial response (CR/PR) to progression/death (from any cause), assessed up to 100 months

Study Arms (1)

Patients with advanced pancreatic cancer that is inoperable and not suitable for local treatment

EXPERIMENTAL

Patients with advanced pancreatic cancer that is inoperable and not suitable for local treatment

Drug: Utidelone injection in combination with gemcitabine

Interventions

Utidelone injection in combination with gemcitabine DRUG

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

Also known as: UTD1

Patients with advanced pancreatic cancer that is inoperable and not suitable for local treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled in the study must meet all of the following criteria:
• Age: 18-75 years old.
• Karnofsky (KPS) physical status score ≥70.
• Those confirmed by histopathology or cytology, inoperable and unsuitable for local treatment This is a malignant tumor of pancreatic ductal epithelium, graded as stage Ⅲ-Ⅳ according to the American Joint Committee on Cancer (AJCC) eighth Edition (T4NxM0-1/TxNxM1), except for pancreatic neuroendocrine tumors;
• Baseline blood routine and biochemical indexes of subjects meet the following standards: hemoglobin ≥90g/L; neutral Granulocyte absolute count (ANC) ≥1.5×109g/L; Platelet ≥100×109/L; glutamine Enzyme (ALT), aspartate aminotransferase (AST) ≤2.5 times the normal upper limit; Serum total bilirubin \<1.5 times the normal upper limit; Serum creatinine \<1 times the normal upper limit; Serum albumin
• ≥30g/L.
• Cardiac function: a) left ventricular ejection fraction (LVEF) ≥50%; b) 12-ECG showed no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment;
• No severe concomitant disease with survival time \<5 years, known peripheral nerve disease ≤ grade 1.
• Agree to and be able to follow the protocol during the study.
• Provide written informed consent before entering the study screening. -

You may not qualify if:

• For patients with pancreatic cancer who had previously received chemotherapy, radiotherapy or immunotherapy.
• Patients with pancreatic neuroendocrine tumors confirmed by histopathology or cytology
• Pregnant or lactating women.
• Women of childbearing age who had a positive pregnancy test at baseline or did not undergo a pregnancy test. Postmenopausal women must Stop menstruation for at least 12 months before pregnancy is not possible.
• Men and women who had sex (with the possibility of procreation) were reluctant to use contraception during the study period.
• Non-melanoma skin cancer and cervical carcinoma in situ were cured in patients with other malignant history in the last 5 years Outside.
• A history of uncontrolled epilepsy, central nervous system disease or mental disorder, as determined by the investigator Clinical severity can prevent the signing of informed consent or affect patient adherence to oral medication.
• Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association May have grade II or worse congestive heart failure or severe cardiac rhythm requiring medical intervention Disorder, or history of myocardial infarction within the last 12 months.
• Those who are severely allergic to polyoxyethylene (35) castor oil, or have used anti-microtubule drugs in the past Severe adverse reactions occurred.
• Known peripheral nerve disease ≥NCICTC, AE grade 2.
• severe uncontrolled recurrent infection, or other severe uncontrolled concomitant disease.
• Moderate or severe renal impairment \[creatinine clearance ≤50ml/min (according to Cockrcoft and Gault equation), or serum creatinine \> upper normal limit (ULN) .
• Acute or chronic active hepatitis B, hepatitis C infection, hepatitis B virus (HBV) DNA \> 2000 IU/ml or 104 copies /ml, Hepatitis C virus (HCV) RNA \> 103 copies /ml, hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive at the same time, human immunity Epidemic defect virus (HIV).
• Allergic to Utidelone or gemcitabine.
• Participants who had received study medication or preparation/treatment (i.e., participating in other trials) within 4 weeks prior to enrollment.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xueying Ding, Prof.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Qi Li, Prof.

CONTACT

+86-13818207333; leeqi2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Unresectable advanced pancreatic cancer

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 3, 2023
• Study Start: March 8, 2023
• Primary Completion: July 8, 2024
• Study Completion: September 8, 2025
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)