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

NCT07160283 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MT-008
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles

  through study completion, an average of 1 year

Secondary Outcomes (2)

• The incidence of grade ≥ 3 thrombocytopenia

  through study completion, an average of 1 year

• The incidence of FN

  through study completion, an average of 1 year

Other Outcomes (2)

• OS

  2 years

• PFS

  1 year

Study Arms (1)

Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat

EXPERIMENTAL

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. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.

Drug: Bile duct cancer cohort; Drug: Pancreatic cancer cohort

Interventions

Bile duct cancer cohort DRUG

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. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.

Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat

Pancreatic cancer cohort DRUG

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. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.

Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat

Eligibility Criteria

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

You may qualify if:

• Age \>18 years, male or female.
• Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment.
• ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up.
• No clinically significant abnormalities in complete blood count, hepatic/renal function, cardiac enzymes, or electrocardiogram (ECG).
• Voluntary participation with good compliance and willingness to undergo safety and survival follow-up.
• Signed written informed consent form prior to enrollment.

You may not qualify if:

• History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease.
• Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiotherapy or steroid therapy.
• Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug.
• 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.
• Concurrent requirement for radiotherapy.
• Known hypersensitivity to any component of the study drug formulation.
• Pregnancy or lactation.
• Any other condition deemed by the investigator to compromise patient safety or study validity.

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• yan hai Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu E Miao, Doctor

CONTACT

17553832219; miaoyue0626@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share