A shield for bone marrow: can a drug stop Chemo's blood cell side effect?
NCT ID NCT07736001
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether a drug called trilaciclib can prevent myelosuppression — a drop in blood cell counts — caused by a type of chemotherapy known as topoisomerase I inhibitor antibody-drug conjugates (ADCs). About 96 cancer patients who are scheduled to receive these ADC drugs will get trilaciclib by infusion four hours before each chemo dose, for two treatment cycles. The main goal is to see how many patients avoid severe neutropenia (a dangerously low level of infection-fighting white blood cells).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trilaciclib
- What this could lead to
- If effective, trilaciclib could become a standard preventive treatment to reduce severe neutropenia and other blood-related side effects from certain chemotherapy-like drugs.
- What could go wrong
- This is an early-phase, single-arm trial with only 96 participants, so results may not generalize. The drug itself may cause side effects, and its benefit over current care is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patient voluntarily participated in this study, signed the informed consent form, had good compliance and cooperated with the follow-up; 2. Age greater than 18 years old, regardless of gender; 3. Malignant tumors diagnosed by histological or cytological examination; 4. Cancer patients whose tumors can be treated with topoisomerase I inhibitor type ADC drugs (Regucitinib, Gosatuzumab, Luconasuzumab, Deconzumab) as evaluated by the investigator; 5. Patients are allowed to have received systemic anti-tumor treatment in the past; 6. ECOG physical status score 0-2; 7. No gastrointestinal obstruction, such as gastric pyloric stenosis or intestinal obstruction; 8. Expected survival period ≥ 12 weeks; 9. Good organ and bone marrow function, defined as follows: Hematological system: Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelets (PLT) ≥ 90×109/L; Hemoglobin: ≥ 90 g/L; Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with Gilbert syndrome, ≤ 3×ULN); Aspartate aminotransferase ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN); Alanine aminotransferase ≤ 2.5×ULN (for patients with liver metastasis: ≤ 5×ULN); Albumin ≥ 30 g/L; Renal function: Creatinine ≤ 1.5×ULN; Creatinine clearance rate (only when creatinine \> 1.5×ULN is calculated): Endogenous creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula); Cardiac function: 12-lead electrocardiogram: No severe arrhythmia, and the mean corrected QT interval (QTc) by Fridericia method (for males) is \< 450 ms, QTc \< 470 ms (for females); Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%; 10. Within 2 weeks before enrollment, no use of granulocyte colony-stimulating factor (g-csf), erythropoiesis-stimulating agents (ESAs), or bone marrow suppression prevention or correction-related drugs or treatments such as red blood cell (RBC) and/or platelet transfusion; 11. Exclude patients who have previously experienced infection or interstitial pneumonia; twelve For the fertile subjects, the serum pregnancy test was negative within 72 hours before the first use of the study drug, and they agreed to use effective contraceptive measures from the time of signing the informed consent form until 180 days after the last use of the investigational drug. Exclusion Criteria: * 1\. No history of myeloid leukemia, myelodysplastic syndrome or concurrent sickle cell disease; 2. Within one week before the blood test during the screening period, received hematopoietic growth factors, blood transfusion or platelet transfusion treatment; 3. Have any active autoimmune diseases or have a history of autoimmune diseases; 4. Within two weeks before the first administration, received systemic corticosteroids (daily \> 10mg prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) on a daily basis; 5. Within 4 weeks before enrollment, had a severe infection requiring intravenous antibiotics treatment or active infection; 6. Severe cardiovascular injury (greater than NYHA II grade congestive heart failure history), unstable angina pectoris or myocardial infarction within the past 6 months, or severe arrhythmia. At screening, QTcF interval \> 480 msec, for patients with implanted ventricular pacemaker, QTcF \> 500 msec; 7. Within 6 months before enrollment, had a stroke or cerebrovascular event; 8. Subjects with a recipient of allogeneic organ transplantation requiring immunosuppressive therapy; 9. Known human immunodeficiency virus (HIV) positive subjects; 10. Uncontrolled active hepatitis B (defined as a positive result for hepatitis B surface antigen HBsAG during the screening period, while the HBV DNA test value is higher than the upper limit of the laboratory department's normal value in the research center; subjects who tested HBV DNA content \< 500 IU/mL within 28 days before randomization and have received at least 4 weeks of local standard antiviral treatment and are willing to continue antiviral treatment during the study can be enrolled); active hepatitis C (defined as a positive result for hepatitis C surface antibody HCsAb during the screening period and positive HCV RNA) subjects; 11. Previously had concurrent other malignant tumors for ≤ 5 years, fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, locally advanced prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery. Patients who are not excluded if they have been fully treated; 12. Expected to need any other form of anti-tumor treatment during the study period; 13. Active brain metastasis; 14. Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first administration; 15. Received live vaccines within 30 days before the first administration of the study treatment; 16. Any medical condition as determined by the investigator that makes the subject unsuitable for enrollment in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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