LA HNSCCPhase 2NCT06978829
Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC
A Phase 2 study testing TP + Cetuximab + Tislelizumab in people with LA HNSCC, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LA HNSCC
- What is being tested?
- TP + Cetuximab + Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;
- Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;
- No prior treatment for head and neck squamous cell carcinoma;
- No prior treatment with cetuximab or PD-(L)1 inhibitors;
- At least one measurable lesion according to RECIST v1.1;
- No gender restriction, age ≥18;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Expected survival period ≥ 3 months;
- Organ function levels meet the following criteria:
- Blood routine: Hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥90×10^9/L;
- Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g/L;
- Cardiac function: Left ventricular ejection fraction >50% as shown by echocardiography.
- Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.
Who cannot join
- Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
- Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;
- Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation >470 ms), and grade I cardiac insufficiency;
- History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
- Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU/mL) or active hepatitis C (positive hepatitis C antibody) patients;
- Patients with active tuberculosis (with exposure history or positive tuberculosis test; accompanied by clinical and/or imaging manifestations);
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- Patients who have undergone major surgery within 4 weeks before the first dose or whose wounds have not fully healed;
- Patients with a clear tendency to bleed;
- Patients with severe complications such as pyloric obstruction, upper gastrointestinal bleeding, gastrointestinal perforation, obstructive jaundice, severe malnutrition, etc.;
- Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;
- Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor is highly likely to invade important blood vessels during treatment, leading to fatal massive bleeding;
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.;
- Patients with active brain metastasis;
- Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer);
- Pregnant or breastfeeding women;
- Patients with severe concomitant diseases that endanger patient safety or affect the completion of the study, as judged by the investigator, and those whom the investigator considers unsuitable for inclusion.
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
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality
Juan Li
About this study
Official title: Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study
This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.
Read the detailed description
This study plans to enroll 42 patients. After screening and qualifying the patients, they will be given the treatment of Cetuximab combined with Tislelizumab and the TP chemotherapy regimen. One cycle lasts for 3 weeks, and a total of 3 cycles will be carried out, followed by efficacy evaluation.
- Patients evaluated as resectable will undergo surgical treatment. After the surgery, based on the postoperative pathology, it will be determined whether radiotherapy is needed. And then, 1 cycle of combined chemotherapy will be continued, followed by 1 - year maintenance treatment with Tislelizumab.
- Patients evaluated as unsuitable for surgery will receive radical radiotherapy, followed by 1 - year maintenance treatment with Tislelizumab, until disease progression, intolerable adverse reactions occur, or the patient refuses to continue treatment.
- Conditions
- LA HNSCC
- Being tested
- TP + Cetuximab + Tislelizumab
- Keywords
- Tislelizumab, Cetuximab, LA HNSCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP + Cetuximab + TislelizumabDrug
Conversion therapy stage:
TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W.
Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total.
Patients who have completed conversion therapy undergo efficacy evaluation.
Radical therapy stage:
Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen.
Evaluated as inoperable: Receive radical radiotherapy.
Maintenance therapy stage:
Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Conversion therapy stage：TP+Cetuximab+Tislelizumab. Radical therapy stage: Those assessed as operable receive curative surgery, while those assessed as inoperable undergo radical radiotherapy.
Maintenance therapy stage: Tislelizumab for 1 year. Receives: Drug: TP + Cetuximab + Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) after conversion treatment. Based on RECIST 1.1.
Measured: 6 months
Secondary outcomes (5)
R0 resection rate
Defined as the proportion of patients in whom no cancer cells are detected at the resection margin microscopically, with no residual cancer cells visible either macroscopically or microscopically, and the lesion is completely excised.
Measured: 6 months
Major Pathological Response Rate (MPR)
Defined as the presence of 10% or less viable tumor cells in the resected specimen following preoperative therapy, as assessed by pathological examination.
Measured: 6 months
Progression free survival (PFS)
Defined as the period from enrollment to disease progress or death.
Measured: up to 5 years
Overall Survival (OS)
Defined as the period from enrollment to death from any cause
Measured: up to 5 years
Adverse Event rate
The rate of adverse event after treatment
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LA HNSCCStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978829
- Sponsor's protocol ID
- 202552
- Status last verified
- Feb 2025
- First submitted
- 16 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06978829
- Acronym / sponsor ID
- 202552
- Conditions
- LA HNSCC
- Keywords
- Tislelizumab, Cetuximab, LA HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 May 2025 (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 prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.
Detailed description
This study plans to enroll 42 patients. After screening and qualifying the patients, they will be given the treatment of Cetuximab combined with Tislelizumab and the TP chemotherapy regimen. One cycle lasts for 3 weeks, and a total of 3 cycles will be carried out, followed by efficacy evaluation.
- Patients evaluated as resectable will undergo surgical treatment. After the surgery, based on the postoperative pathology, it will be determined whether radiotherapy is needed. And then, 1 cycle of combined chemotherapy will be continued, followed by 1 - year maintenance treatment with Tislelizumab.
- Patients evaluated as unsuitable for surgery will receive radical radiotherapy, followed by 1 - year maintenance treatment with Tislelizumab, until disease progression, intolerable adverse reactions occur, or the patient refuses to continue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: TP + Cetuximab + TislelizumabConversion therapy stage：TP+Cetuximab+Tislelizumab. Radical therapy stage: Those assessed as operable receive curative surgery, while those assessed as inoperable undergo radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;
- Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;
- No prior treatment for head and neck squamous cell carcinoma;
- No prior treatment with cetuximab or PD-(L)1 inhibitors;
- At least one measurable lesion according to RECIST v1.1;
Key exclusion criteria (16 listed)
- Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
- Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;
- Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation >470 ms), and grade I cardiac insufficiency;
- History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
- Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU/mL) or active hepatitis C (positive hepatitis C antibody) patients;
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 |
|---|---|---|
| TP + Cetuximab + TislelizumabConversion therapy stage: TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W. Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total. Patients who have completed conversion therapy undergo efficacy evaluation. Radical therapy stage: Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen. Evaluated as inoperable: Receive radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment. | Drug | Experimental arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 6 months
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) after conversion treatment. Based on RECIST 1.1.
5 secondary outcomes
R0 resection rate
Time frame: 6 months
Major Pathological Response Rate (MPR)
Time frame: 6 months
Progression free survival (PFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Adverse Event rate
Time frame: up to 2 years
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 18 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for LA HNSCC
RecruitingPhase 3
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Carcinoma, Squamous Cell
RecruitingPhase 2
Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Active, not recruitingPhase 3
Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)
HNSCC
Not yet recruitingPhase 2
Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC
HPV-unrelated Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 3
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Head and Neck Neoplasms
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 TP + Cetuximab + Tislelizumab in people with LA HNSCC, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 13 inclusion and 16 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 18 May 2025. 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 Juan Li (86+13883272120, lljuan1019@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6 months). 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 18 May 2025.