Squamous Cell Carcinoma of Head and NeckPhase 2NCT06895369
The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC
A Phase 2 study testing Pucotenlimab in people with Squamous Cell Carcinoma of Head and Neck, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). Study Design: This is a single-arm interventional study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Pucotenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2033
- 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
- Age: 18 to 70 years old.
- Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).
- Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
- Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
- Performance Status: ECOG performance status of 0-1.
- Surgical Eligibility: Deemed eligible for elective standard surgery followed by standard adjuvant chemoradiotherapy/radiotherapy, as assessed by the investigator.
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- Autoimmune Disease: No active autoimmune diseases.
- Concurrent Malignancy: No concurrent malignancies.
- Life Expectancy: ≥6 months.
- Biomarker Testing: Available tumor tissue samples for PD-L1 testing via Combined Positive Score (CPS) using 22C3 pharmDx assay (DAKO).
- Hematologic Parameters:
- ANC ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥100 g/L, WBC ≥3.5×10⁹/L.
- No transfusion within 7 days or bleeding tendency.
- Liver Function: ALT, AST, ALP, and total bilirubin ≤1.5× upper limit of normal (ULN).
- Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance >60 mL/min.
- HPV Status: HPV status confirmed via p16 immunohistochemistry (IHC) and/or in situ hybridization (ISH).
- Informed Consent: Voluntarily participates and signs informed consent. For participants unable to consent due to incapacity, consent must be provided by a legally authorized representative. For illiterate participants, an impartial witness must attest to the informed consent process.
Who cannot join
- Cachexia or multiple organ failure.
- Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
- Concurrent second primary malignancy (e.g., esophageal cancer).
- Severe active infection requiring systemic therapy.
- Uncontrolled comorbid medical conditions that may compromise protocol compliance, per investigator judgment, including:
- Severe cardiovascular/cerebrovascular diseases,
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- Uncontrolled diabetes/hypertension,
- Active peptic ulcer,
- Uncontrolled infections.
- Dementia, altered mental status, or cognitive impairment affecting informed consent or questionnaire completion.
- Grade ≥2 peripheral neuropathy (per CTCAE v5.0).
- Grade ≥2 hearing impairment (per CTCAE v5.0).
- History of malignancy within the past 5 years (excluding cured non-melanoma skin cancer or carcinoma in situ).
- Known HIV-positive status or AIDS.
- Nasopharyngeal carcinoma or squamous cell carcinoma originating outside oral cavity, oropharynx, hypopharynx, or larynx (e.g., sinonasal tract, paranasal sinuses, or unknown primary).
- Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
- Systemic glucocorticoids (>10 mg/day prednisone equivalent) or immunosuppressive agents within 14 days prior to randomization.
- Exceptions: Inhaled/topical steroids or physiologic replacement doses for adrenal insufficiency.
- Pregnancy, breastfeeding, or refusal of contraception by subjects of childbearing potential.
- Active infection requiring treatment or systemic antimicrobial use within 1 week prior to first dose.
- Live vaccines administered within 30 days before first dose or during the study.
- Vulnerable populations (e.g., severe psychiatric disorders, cognitive impairment, critically ill patients, prisoners, pregnant individuals).
- Other conditions deemed by the investigator to preclude safe study participation.
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
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, 310016
Xiaohua Jiang, Master, 13777469596 ext. 086
About this study
Official title: The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy Regimen (Cisplatin and Docetaxel) as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC).
Study Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination.
Read more
Endpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS).
Hypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Pucotenlimab
- Keywords
- Pucotenlimab, Squamous Cell Carcinoma of Head and Neck, 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.
PucotenlimabDrug
Also called Cisplatin, Docetaxel
patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients will receive 3 cycles of Pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination. Receives: Drug: Pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Pathological complete response rate (pCR) after surgery
Measured: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
Secondary outcomes (1)
Major pathological response rate
major pathological response rate (MPR) of the treatment regimen
Measured: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohua Jiang, Master, Study chair, Sir Run Run Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895369
- Sponsor's protocol ID
- XiaohuaJiang
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy Regimen (Cisplatin and Docetaxel) as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT06895369
- Acronym / sponsor ID
- XiaohuaJiang
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Pucotenlimab, Squamous Cell Carcinoma of Head and Neck, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 26 Mar 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.
Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC).
Study Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination.
Endpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS).
Hypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.
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: PucotenlimabPatients will receive 3 cycles of Pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age: 18 to 70 years old.
- Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).
- Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
- Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
- Performance Status: ECOG performance status of 0-1.
Key exclusion criteria (23 listed)
- Cachexia or multiple organ failure.
- Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
- Concurrent second primary malignancy (e.g., esophageal cancer).
- Severe active infection requiring systemic therapy.
- Uncontrolled comorbid medical conditions that may compromise protocol compliance, per investigator judgment, including:
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 |
|---|---|---|
| PucotenlimabAlso: Cisplatin, Docetaxelpatients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment | Drug | experimental group |
Primary outcome
Pathological complete response rate
Time frame: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
Pathological complete response rate (pCR) after surgery
1 secondary outcome
Major pathological response rate
Time frame: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
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 26 Mar 2025.
- Individual participant dataSharing planned: No. We have no IPD sharing plan.
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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.
Xiaohua Jiang, Master study chair
Sir Run Run Hospital
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 Pucotenlimab in people with Squamous Cell Carcinoma of Head and Neck, run by Sir Run Run Shaw 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 17 inclusion and 23 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: opening soon, as of the sponsor's last update on 26 Mar 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 Xiaohua Jiang, Master (13777469596 ext. 086, jxhua2008@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.). 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 26 Mar 2025.