Head and Neck Cancer Squamous Cell CarcinomaPhase 2CCRT，LA-HNSCCNCT06752798
Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
A Phase 2 study testing Trilaciclib + Cisplatin in people with Head and Neck Cancer Squamous Cell Carcinoma, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer Squamous Cell Carcinoma
- What is being tested?
- Trilaciclib + Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral cavity, oropharynx, hypopharynx, and larynx, excluding cancers of the lip and nasopharynx).
- Indications for surgery and postoperative chemotherapy plus radiotherapy, and meeting the following conditions:
- (1) Staging of T1-4N0-3M0, having undergone radical surgery;
- (2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves/blood vessels/lymphatic vessels.
- ECOG performance status score of 0-1.
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- Normal major organ function, meeting the following criteria:
- (1) Hematology standards (no blood transfusion or blood products within 14 days): a. HB ≥ 90 g/L; b. Neu ≥ 1.5×10^9/L; c. PLT ≥ 100×10^9/L;
- (2) Biochemical criteria: a. TBIL < 1.5× upper limit of normal (ULN); b. ALT and AST < 2.5× ULN; c. Serum Cr ≤ 1.0× ULN or creatinine clearance rate > 60 ml/min.
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use reliable contraception during the study and for a specified period after the last dose of the study drug.
- Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug. For male participants, they must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug or have undergone surgical sterilization.
- The subjects voluntarily join this study and sign the informed consent form.
Who cannot join
- Pathologically confirmed non-squamous cell carcinoma.
- Patients with recurrence or distant metastasis (M1).
- Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.
- Pregnant or breastfeeding women.
- Previous or concurrent other malignancies.
- Patients with other uncontrolled serious diseases.
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- Abnormal function of vital organs such as the heart, brain, or lungs: Hypertension that cannot be controlled to normal range with antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, and Grade II heart failure; stroke or cardiovascular events within 6 months prior to enrollment; abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with a tendency to bleed or receiving thrombolytic or anticoagulant therapy; clear tendency to bleed; patients with positive proteinuria (urine protein test 2+ or above, or 24-hour urine protein quantification > 1.0 g).
- Active infections requiring systemic treatment, such as tuberculosis.
- Previous hematopoietic stem cell or bone marrow transplant.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are eligible: HBV viral load must be < 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary; active HCV infection subjects (HCV antibody positive and HCV-RNA levels above the detection limit).
- History of substance abuse that cannot be abstained from or mental disorders.
- Allergy to the study drug or its components.
- Any other conditions that the investigator judges may affect the conduct of the clinical study and the determination of the study results.
- Concurrent participation in another therapeutic clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan, 410000
Feng Liu, 073189762191, liufeng@hnca.org.cn
About this study
Official title: Bone Marrow Protective Effect of Trilaciclib in Postoperative Concurrent Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Phase 2 Clinical Study
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery
Read the detailed description
Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression and approved by the FDA for small cell lung cancer patients in 2021.
- Being tested
- Trilaciclib + Cisplatin
- Keywords
- Trilaciclib, Head and neck cancer, Adjuvant treatment, chemoradiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilaciclib + CisplatinDrug
Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib + Cisplatin | Experimental | Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session.
Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times. Receives: Drug: Trilaciclib + Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3/4 Neutropenia
Neutrophils ≤ 1.0*109/L
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Secondary outcomes (5)
Incidence of Grade 3/4 Thrombocytopenia during Chemotherapy
Platelets≤ 50*109/L
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Grade 3/4 Anemia during Chemotherapy
hemoglobin<80g/L
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Febrile Neutropenia
ANC <0.5×10^9/L or ANC between 0.5 and 1×10^9/L (Grade 3) but expected to drop to <0.5×10^9/L within the next 48 hours;temperature ≥38.3°C or ≥38.0°C for more than 1 hour.
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Platelet Transfusion
Incidence of Platelet Transfusion
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Red Blood Cell Transfusion
Incidence of Red Blood Cell Transfusion
Measured: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752798
- Sponsor's protocol ID
- SMA-HNSCC-001
- Acronym
- CCRT，LA-HNSCC
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Protective Effect of Trilaciclib in Postoperative Concurrent Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT06752798
- Acronym / sponsor ID
- CCRT，LA-HNSCC / SMA-HNSCC-001
- Keywords
- Trilaciclib, Head and neck cancer, Adjuvant treatment, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery
Detailed description
Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression and approved by the FDA for small cell lung cancer patients in 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group assignment
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib + Cisplatin | Experimental | Drug: Trilaciclib + CisplatinTrilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- (1) Staging of T1-4N0-3M0, having undergone radical surgery;
- (2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves/blood vessels/lymphatic vessels.
- (1) Hematology standards (no blood transfusion or blood products within 14 days): a. HB ≥ 90 g/L; b. Neu ≥ 1.5×10^9/L; c. PLT ≥ 100×10^9/L;
- (2) Biochemical criteria: a. TBIL < 1.5× upper limit of normal (ULN); b. ALT and AST < 2.5× ULN; c. Serum Cr ≤ 1.0× ULN or creatinine clearance rate > 60 ml/min.
Key exclusion criteria (15 listed)
- Pathologically confirmed non-squamous cell carcinoma.
- Patients with recurrence or distant metastasis (M1).
- Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.
- Pregnant or breastfeeding women.
- Previous or concurrent other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trilaciclib + CisplatinTrilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times. | Drug | Trilaciclib + Cisplatin |
Primary outcome
Incidence of Grade 3/4 Neutropenia
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Neutrophils ≤ 1.0*109/L
5 secondary outcomes
Incidence of Grade 3/4 Thrombocytopenia during Chemotherapy
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Grade 3/4 Anemia during Chemotherapy
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Febrile Neutropenia
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Platelet Transfusion
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Incidence of Red Blood Cell Transfusion
Time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib + Cisplatin in people with Head and Neck Cancer Squamous Cell Carcinoma, run by Hunan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Liu, Doctoral Degree (+86073189762191, liufeng@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3/4 Neutropenia (time frame: From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.