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Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

NCT06955156 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-02

No results posted yet for this study

Summary

Trilaciclib is a highly potent, selective, and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.

Conditions

Interventions

DRUG

Trilaciclib

trilaciclib 240mg/m2 ivgtt d1 Q3w; anti-PD-1 antibody 200mg ivgtt d1 Q3w; Paclitaxel-albumin 250mg/m2 ivgtt d1 Q3w or 125mg/m2 ivgtt d1,d8 Q3w; carboplatin AUC=5 ivgtt d1 Q3w; Review every 2 cycles until the best efficacy or intolerable toxicity, usually 6-8 cycles;

Sponsors & Collaborators

  • QIAO LI

    lead OTHER

Principal Investigators

  • Qiao Li · National Cancer Center/Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2025-05-01
Completion
2025-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955156 on ClinicalTrials.gov