Head and Neck Squamous Cell CarcinomaPhase 2NCT05272696
Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC
A Phase 2 study testing Nab-paclitaxel, cisplatin and Pembrolizumab combination, surgery and Adjuvant Chemoradiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nab-paclitaxel, cisplatin and Pembrolizumab combination, surgery and Adjuvant Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Jan 2026
- 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
- Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal and hypopharynx) with locoregionally-advanced disease stage III or IVA without metastasis , previously untreated (AJCC 8th) and had at least one tumour lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Measurable disease based on RECIST 1.1
- ECOG performance status 0-1
- Men and women, Age ≥18 and ≤ 70 years at the time of signing informed consent,
- Adequate hepatic, cardiac and renal function as demonstrated by 1) Hematology: ANC≥1.5×10^9 /L, HGB≥9 g/dL, PLT≥80×10^9 /L; 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min; 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN and ALP≤5 x ULN.
- Female subjects of childbearing potential should have a negative pregnancy test result within 28 days prior to enrollment. If the result is more than 7 days before receiving the first dose of study medication, a urine pregnancy test is required for verification.
- Voluntary informed consent, joining the study with good compliance
Who cannot join
- Active, known, or suspected autoimmune disease or Type I diabetes or hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic treatment.
- currently received systemic steroid therapy with dose superior to 10 mg/day of prednisone or equivalent or any other form of immunosuppressive therapy within 14 days prior to the enrollment
- Has known active Hepatitis B (e.g., HBsAg reactive and HBV DNA≥1×10^4 copies /mL) or Hepatitis C or HIV
- Active pulmonary tuberculosis (TB) infection was judged according to chest X-ray examination/CT, sputum examination and clinical physical examination.
- Patients with severe heart disease include congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and intractable hypertension.
- Pregnant or breastfeeding women.
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- The patient (male or female) has the possibility of fertility, but is unwilling or does not take effective contraceptive measures.
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device
- Has had another known invasive malignancy or unresectable cancer.
- Received a live vaccine within 30 days of planned start of study therapy.
- History or current evidence of any condition, therapy, or laboratory abnormality that might influence the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Siyi Zhang
About this study
Official title: Induction Therapy With Nab-paclitaxel, Cisplatin and Pembrolizumab in Untreated Locally Advanced Head and Neck Squamous Cell Carcinoma
To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
Read the detailed description
This study is a non-randomized, single-arm, single-institutional phase II study including patients with Locally Advanced Head and Neck Squamous Cell Carcinoma eligible for resection. Nab-paclitaxel (260 mg/m² IV), cisplatin (75 mg/m² IV), and Pembrolizumab (200 mg IV) will be administered for two cycles of three weeks duration each. Surgery or CRT will be performed after induction therapy. Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. Patients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors. Objective response rate, safety, and rate of organ preservation will be the primary outcome measures.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nab-paclitaxel, cisplatin and Pembrolizumab combination, surgery, Adjuvant Chemoradiotherapy, Radical concurrent chemoradiotherapy
- 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.
Nab-paclitaxel, cisplatin and Pembrolizumab combinationDrug
Pembrolizumab in combination with Nab-paclitaxel and cisplatin as induction therapy
surgeryProcedure or surgery
Patients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly.
Adjuvant ChemoradiotherapyRadiation
After surgery, adjuvant Chemoradiotherapy or radiotherapy will be given for patients with high-risk factors.
Radical concurrent chemoradiotherapyDrug
Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive Radical concurrent chemoradiotherapy. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All enrolled patients will receive two cycles of chemotherapy consisting of nab-paclitaxel (260 mg/m² on days 1), cisplatin (75 mg/m² on days 1), and Pembrolizumab (200 mg on days 1). Each cycle is repeated every 21 days.
After induction therapy, patients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors.
After induction therapy, patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. Receives: Drug: Nab-paclitaxel, cisplatin and Pembrolizumab combination; Procedure: surgery; Radiation: Adjuvant Chemoradiotherapy; Drug: Radical concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR) will be determinated by evaluation of Complete Response (CR) and Partial Response (PR)
Measured: 24 months
Evaluation of Safety
Toxicity will be evaluated according to NCI-CTCAE v4.03
Measured: 24 months
Rate of organ preservation
After two courses of induction treatment, MDT discussed whether to accept surgical treatment or concurrent chemoradiotherapy, and the proportion of patients whose organ function can be preserved after treatment.
Measured: 24 months
Secondary outcomes (2)
overall survival (OS)
Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 24 months
progression-free survival (PFS)
Defined from date of registration to date of first documentation of progression or death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MA HAIQING, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272696
- Sponsor's protocol ID
- INDUCTION THERAPY
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2022
- Last updated
- 1 Jul 2025
- Results posted
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Therapy With Nab-paclitaxel, Cisplatin and Pembrolizumab in Untreated Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05272696
- Acronym / sponsor ID
- INDUCTION THERAPY
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Mar 2022 (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 study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
Detailed description
This study is a non-randomized, single-arm, single-institutional phase II study including patients with Locally Advanced Head and Neck Squamous Cell Carcinoma eligible for resection. Nab-paclitaxel (260 mg/m² IV), cisplatin (75 mg/m² IV), and Pembrolizumab (200 mg IV) will be administered for two cycles of three weeks duration each. Surgery or CRT will be performed after induction therapy. Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. Patients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors. Objective response rate, safety, and rate of organ preservation 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 | Experimental | Drug: Nab-paclitaxel, cisplatin and Pembrolizumab combination, Procedure: surgery, Radiation: Adjuvant Chemoradiotherapy, Drug: Radical concurrent chemoradiotherapyAll enrolled patients will receive two cycles of chemotherapy consisting of nab-paclitaxel (260 mg/m² on days 1), cisplatin (75 mg/m² on days 1), and Pembrolizumab (200 mg on days 1). Each cycle is repeated every 21 days. After induction therapy, patients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors. After induction therapy, patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal and hypopharynx) with locoregionally-advanced disease stage III or IVA without metastasis , previously untreated (AJCC 8th) and had at least one tumour lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Measurable disease based on RECIST 1.1
- ECOG performance status 0-1
- Men and women, Age ≥18 and ≤ 70 years at the time of signing informed consent,
- Adequate hepatic, cardiac and renal function as demonstrated by 1) Hematology: ANC≥1.5×10^9 /L, HGB≥9 g/dL, PLT≥80×10^9 /L; 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min; 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN and ALP≤5 x ULN.
Key exclusion criteria (11 listed)
- Active, known, or suspected autoimmune disease or Type I diabetes or hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic treatment.
- currently received systemic steroid therapy with dose superior to 10 mg/day of prednisone or equivalent or any other form of immunosuppressive therapy within 14 days prior to the enrollment
- Has known active Hepatitis B (e.g., HBsAg reactive and HBV DNA≥1×10^4 copies /mL) or Hepatitis C or HIV
- Active pulmonary tuberculosis (TB) infection was judged according to chest X-ray examination/CT, sputum examination and clinical physical examination.
- Patients with severe heart disease include congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and intractable hypertension.
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 |
|---|---|---|
| Nab-paclitaxel, cisplatin and Pembrolizumab combinationPembrolizumab in combination with Nab-paclitaxel and cisplatin as induction therapy | Drug | Experimental |
| surgeryPatients with PR but the maximum diameter of tumor > 3cm or SD or PD can receive surgery directly. | Procedure or surgery | Experimental |
| Adjuvant ChemoradiotherapyAfter surgery, adjuvant Chemoradiotherapy or radiotherapy will be given for patients with high-risk factors. | Radiation | Experimental |
| Radical concurrent chemoradiotherapyPatients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive Radical concurrent chemoradiotherapy. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. | Drug | Experimental |
Primary outcome
Objective response rate
Time frame: 24 months
Objective response rate (ORR) will be determinated by evaluation of Complete Response (CR) and Partial Response (PR)
Evaluation of Safety
Time frame: 24 months
Toxicity will be evaluated according to NCI-CTCAE v4.03
Rate of organ preservation
Time frame: 24 months
After two courses of induction treatment, MDT discussed whether to accept surgical treatment or concurrent chemoradiotherapy, and the proportion of patients whose organ function can be preserved after treatment.
2 secondary outcomes
overall survival (OS)
Time frame: 24 months
progression-free survival (PFS)
Time frame: 24 months
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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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 Nab-paclitaxel, cisplatin and Pembrolizumab combination, surgery and Adjuvant Chemoradiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Guangdong Provincial People's 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 7 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 Haiqing Ma (+86 18575604025, mahaiqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 24 months). The study lists 3 primary outcomes in all. 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 1 Jul 2025.