---
title: The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer
nct_id: NCT07160283
overall_status: NOT_YET_RECRUITING
phase: PHASE2
sponsor: The Second Affiliated Hospital of Shandong First Medical University
study_type: INTERVENTIONAL
primary_condition: Biliary Tract Neoplasms
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07160283.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07160283"
ct_last_update_post_date: 2025-09-08
last_seen_at: "2026-05-12T07:06:24.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer

**NCT ID:** [NCT07160283](https://clinicaltrials.gov/study/NCT07160283)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 96
- **Lead Sponsor:** The Second Affiliated Hospital of Shandong First Medical University
- **Conditions:** Biliary Tract Neoplasms, Pancreatic Neoplasms
- **Start Date:** 2025-09-01
- **Completion Date:** 2028-09-01
- **CT.gov Last Update:** 2025-09-08

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## 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.
- **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.

## Primary Outcomes

- **Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles** _(time frame: through study completion, an average of 1 year)_

## Secondary Outcomes

- **The incidence of grade ≥ 3 thrombocytopenia** _(time frame: through study completion, an average of 1 year)_
- **The incidence of FN** _(time frame: through study completion, an average of 1 year)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07160283.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07160283*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*