$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer

2025-09-01

2027-09-01

2028-09-01

96

Study Overview

The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer

Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.

N/A

  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms
  • DRUG: Bile duct cancer cohort
  • DRUG: Pancreatic cancer cohort
  • MT-008

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-08-16  

N/A  

2025-08-29  

2025-08-29  

N/A  

2025-09-08  

2025-09-08  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat

Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regime

DRUG: Bile duct cancer cohort

  • Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regime

DRUG: Pancreatic cancer cohort

  • rilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimen
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cyclesthrough study completion, an average of 1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
The incidence of grade ≥ 3 thrombocytopeniathrough study completion, an average of 1 year
The incidence of FNthrough study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yu E Miao, Doctor

Phone Number: 17553832219

Email: miaoyue0626@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age >18 years, male or female. 2. Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment. 3. ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up. 4. No clinically significant abnormalities in complete blood count, hepatic/renal function, cardiac enzymes, or electrocardiogram (ECG). 5. Voluntary participation with good compliance and willingness to undergo safety and survival follow-up. 6. Signed written informed consent form prior to enrollment.
    Exclusion Criteria:
    1. History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease. 2. Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiotherapy or steroid therapy. 3. Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug. 4. History of interstitial lung disease, slowly progressive dyspnea with dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, multiple allergies, or peripheral arterial disease. 5. Concurrent requirement for radiotherapy. 6. Known hypersensitivity to any component of the study drug formulation. 7. Pregnancy or lactation. 8. Any other condition deemed by the investigator to compromise patient safety or study validity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: yan hai Liu, The Second Affiliated Hospital of Shandong First Medical University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate