Combining Utidelone and Gemcitabine for Advanced Pancreatic Cancer Treatment

A Multicenter, One-arm Phase II Clinical Study of Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer

This study is testing if a new treatment combining Utidelone and gemcitabine can help people with advanced pancreatic cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05795920 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Utidelone injection in combination with gemcitabine as a first-line chemotherapy for patients with unresectable advanced pancreatic cancer. It is a multicenter, single-arm phase II trial that aims to assess progression-free survival, overall survival, and response rates using RECIST v1.1 criteria. The treatment regimen includes Utidelone administered daily for five days and gemcitabine given on specific days in 21-day cycles, with tumor assessments conducted every six weeks. The study will enroll 92 patients across six centers and monitor safety and adverse events throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable pancreatic cancer and a Karnofsky performance status score of 70 or higher.

Not a fit: Patients with pancreatic neuroendocrine tumors or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced pancreatic cancer.

How similar studies have performed: While the combination of chemotherapy agents is common, the specific use of Utidelone with gemcitabine in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

Patients enrolled in the study must meet all of the following criteria:

1. Age: 18-75 years old.
2. Karnofsky (KPS) physical status score ≥70.
3. 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;
4. 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.
5. 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;
6. No severe concomitant disease with survival time \<5 years, known peripheral nerve disease ≤ grade 1.
7. Agree to and be able to follow the protocol during the study.
8. Provide written informed consent before entering the study screening. -

Exclusion Criteria:

1. For patients with pancreatic cancer who had previously received chemotherapy, radiotherapy or immunotherapy.
2. Patients with pancreatic neuroendocrine tumors confirmed by histopathology or cytology
3. Pregnant or lactating women.
4. 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.
5. Men and women who had sex (with the possibility of procreation) were reluctant to use contraception during the study period.
6. Non-melanoma skin cancer and cervical carcinoma in situ were cured in patients with other malignant history in the last 5 years Outside.
7. 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.
8. 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.
9. Those who are severely allergic to polyoxyethylene (35) castor oil, or have used anti-microtubule drugs in the past Severe adverse reactions occurred.
10. Known peripheral nerve disease ≥NCICTC, AE grade 2.
11. severe uncontrolled recurrent infection, or other severe uncontrolled concomitant disease.
12. Moderate or severe renal impairment \[creatinine clearance ≤50ml/min (according to Cockrcoft and Gault equation), or serum creatinine \> upper normal limit (ULN) .
13. 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).
14. Allergic to Utidelone or gemcitabine.
15. Participants who had received study medication or preparation/treatment (i.e., participating in other trials) within 4 weeks prior to enrollment.
16. Patients who were not eligible to participate in the study for any reason determined by the investigator.

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Where this trial is running

Shanghai, Shanghai

• Shanghai First People's Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Qi Li, Prof.

Conditions Pancreatic Neoplasms