Hend and Neck Squamous Cell Carcinoma Locally Advanced OperablePhase 2CZCNRHNSCCNCT06107114
Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Cetuximab, Zimberelimab and Docetaxel in people with Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable, run by Xuekui Liu at 1 site in China.
Trial summary
This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperative… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable
- What is being tested?
- Cetuximab, Zimberelimab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy).
- Clinical stage:T2N2-3M0,T3-4N0-3M0 (AJCC 8th editionstaging).
- Age: 18 to 70 years.
- PS score (see Appendix Table 1; performance status score of 0 or 1).
- Patients evaluated by a head and neck oncologist as resectable with no distant metastases.
- Patients with at least one measurable lesion according to RECIST version 1.1 criteria.
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- Patients' toxicities assessed according to CTCAE version 4.03 criteria.
- Patients with normal organ function (heart,brain, lungs, kidneys) and suitable for surgery:
- Hematology: White blood cells ≥ 3500/μL,neutrophils ≥1,800/pL, hemoglobin ≥ 9 g/dL, platelets ≥100,000/μL;
- Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be included), AST and ALT ≤3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3 g/dL; c.Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula.
- Patients have signed an informed consent form, are willing and able to comply with the study's visit, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies.
- Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
- Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician.
- Abnormal coagulation function:(PT > 16s,APTT>53s,TT> 21s, Fib < 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy.
- Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3).
- Laboratory values not meeting relevant criteria within 7 days prior to enrollment.
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- Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies,anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or checkpoint pathways).
- Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need for systemic or local use of corticosteroids at immunosuppressive doses prior to enrollment.
- HIV-positive individuals;HBsAg-positive individuals with positive HBV DNA copy number (quantitative test≥1000 cps/ml); positive chronic hepatitis C blood screening(HCV antibody positive).
- Traditional herbal medicine used for anti-tumor purposes within 4 weeks before randomization.
- Women of childbearing potential with a positive pregnancy test and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-center, Phase II Trial of Cetuximab+Zimberelimab Combined With Platinum-containing Dual-agent Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperative administration of Cetuximab+ Zimberelimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma(HNSCC) who are about to undergo surgery.
Read the detailed description
In this study, eligible subject will be enrolled into study arm to accept study treatment objective response rate will be the primary outcome measures.
- Keywords
- head and neck squamous cell carcinoma, Cetuximab, Zimberelimab, neoadjuvant therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Cetuximab 400mg/m2 (The first week), 250mg/m2(Follow-up weekly) The drug was administered every week (QW). The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.
ZimberelimabDrug
Zimberelimab 240 mg, The drug was administered every week (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.
DocetaxelDrug
Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.
CisplatinDrug
Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with locally advanced operable head and neck squamous cell carcinoma Receives: Drug: Cetuximab; Drug: Zimberelimab; Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: 9 weeks
Secondary outcomes (6)
PCR
pathological Complete Response
Measured: 9 weeks
MPR
Major Pathological Response
Measured: 9 weeks
DCR
Disease Control Rate
Measured: 2 years
PFS
Progression-Free survival
Measured: 2 years
OS
Overall survival
Measured: 5 years
Adverse Events Graded By Ctcae V5.0
Percentage of adverse events that are possibly, probably related to study treatment per Criteria for Adverse Events version 5(CTCAE v5.0)
Measured: 90 days after the first dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hend and Neck Squamous Cell Carcinoma Locally Advanced OperableStudies 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
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuekui Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuekui Liu, Sun Yat-sen University
- Investigators
- Xuekui Liu, Principal investigator, Sun Yat Sun University Cancer Center, 651 Dongfeng East Road
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107114
- Sponsor's protocol ID
- 2023-FXY-099-HNC
- Acronym
- CZCNRHNSCC
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-center, Phase II Trial of Cetuximab+Zimberelimab Combined With Platinum-containing Dual-agent Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06107114
- Acronym / sponsor ID
- CZCNRHNSCC / 2023-FXY-099-HNC
- Keywords
- head and neck squamous cell carcinoma, Cetuximab, Zimberelimab, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Xuekui LiuUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperative administration of Cetuximab+ Zimberelimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma(HNSCC) who are about to undergo surgery.
Detailed description
In this study, eligible subject will be enrolled into study arm to accept study treatment objective response rate will be the primary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Cetuximab, Drug: Zimberelimab, Drug: Docetaxel, Drug: CisplatinPatients with locally advanced operable head and neck squamous cell carcinoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy).
- Clinical stage:T2N2-3M0,T3-4N0-3M0 (AJCC 8th editionstaging).
- Age: 18 to 70 years.
- PS score (see Appendix Table 1; performance status score of 0 or 1).
- Patients evaluated by a head and neck oncologist as resectable with no distant metastases.
Key exclusion criteria (11 listed)
- History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies.
- Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
- Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician.
- Abnormal coagulation function:(PT > 16s,APTT>53s,TT> 21s, Fib < 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy.
- Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3).
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 |
|---|---|---|
| CetuximabCetuximab 400mg/m2 (The first week), 250mg/m2(Follow-up weekly) The drug was administered every week (QW). The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies. | Drug | Experimental group |
| ZimberelimabZimberelimab 240 mg, The drug was administered every week (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies. | Drug | Experimental group |
| DocetaxelDocetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles. | Drug | Experimental group |
| CisplatinCisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles. | Drug | Experimental group |
Primary outcome
ORR
Time frame: 9 weeks
overall response rate
6 secondary outcomes
PCR
Time frame: 9 weeks
MPR
Time frame: 9 weeks
DCR
Time frame: 2 years
PFS
Time frame: 2 years
OS
Time frame: 5 years
Adverse Events Graded By Ctcae V5.0
Time frame: 90 days after the first dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Xuekui Liu principal investigator
Sun Yat Sun University Cancer Center, 651 Dongfeng East Road
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 Cetuximab, Zimberelimab and Docetaxel in people with Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable, run by Xuekui Liu 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuekui Liu (08613609713406, Liuxk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 9 weeks). 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 22 Nov 2023.