Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaPhase 2PIONEER-HNNCT07354984
A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Drug Combination Therapy in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Drug Combination Therapy
- 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
- 1 Jan 2026to 31 Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with no deterioration within 2 weeks prior to enrollment.
- Age ≥ 18 years and ≤ 75 years
- Patients with pathologically and/or radiologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx and larynx), who have previously failed treatment with PD-1 (L1) inhibitors and platinum-based drugs. The two types of drugs could be administered as a first-line combination regimen or sequential therapy, with the number of prior treatment lines not exceeding two. If disease progression occurs during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy, or within 6 months after the discontinuation of such treatment, the medications used during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy (including platinum-based drugs, anti-EGFR monoclonal antibodies, PD-1 (L1) inhibitors, etc.) shall be regarded as first-line treatment. Discontinuation or dose reduction of one drug during treatment, or replacement of platinum-based drugs, fluorouracil-based drugs or PD-1 (L1) inhibitors without disease progression shall be counted as the same line of treatment.
- At least one radiologically measurable lesion according to RECIST v1.1
- Assessed by the investigator as not amenable to local therapy (e.g., surgery ± radiotherapy)
- PD-L1 Combined Positive Score (CPS) ≥ 1
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- Adequate organ function
- For women of childbearing potential, the result of serum or urine pregnancy test within 7 days prior to the first administration of the study drug shall be negative. If the urine pregnancy test result is positive or cannot be confirmed as negative, a serum pregnancy test shall be required for confirmation.
- The patient voluntarily participates in the study, signs the informed consent form, and is able to comply with the study schedule for follow-up visits, treatment plans, laboratory tests, and other research procedures.
Who cannot join
- A history of malignant tumor is known.
- Residual toxic reactions caused by prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc.) (excluding alopecia, fatigue and grade 2 hypothyroidism), or clinically significant laboratory test abnormalities > grade 1 (CTCAE v5.0)
- Known to have active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate in the study, provided that their disease is stable.
- A history of severe hypersensitivity reactions to taxanes or other monoclonal antibodies.
- Has any contraindication to the study drugs of this project (docetaxel, nimotuzumab, and camrelizumab)
- Uncontrolled pleural, peritoneal, pelvic or pericardial effusion requiring drainage at least once a month.
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- Uncontrolled or poorly controlled heart diseases, including a history of congestive heart failure (CHF) ≥ Grade 2 (per CTCAE v5.0 or NYHA classification), myocardial infarction, unstable angina pectoris, ventricular tachycardia or torsades de pointes within 6 months prior to enrollment, or cardiac arrhythmias requiring treatment, such as complete left bundle branch block or third-degree atrioventricular block.
- Pulmonary embolism or deep vein thrombosis occurring within 3 months prior to the first administration of the study drug (excluding catheter-related thrombosis from implanted ports or PICC lines)
- A history of or current interstitial pneumonia, severe chronic obstructive pulmonary disease complicated with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Any severe or uncontrolled systemic diseases, including uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), diabetes mellitus (glycated hemoglobin (HbA1c) > 8%), etc.
- Patients with active bleeding, a history of coagulation disorders, or those receiving coumarin anticoagulant therapy.
- Known to have active hepatitis B or hepatitis C.
- Complicated with severe, uncontrolled infections, or known human immunodeficiency virus (HIV) infection (positive for HIV antibodies), or diagnosed with acquired immunodeficiency syndrome (AIDS); or with uncontrolled autoimmune diseases; or with a history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or previous solid organ transplantation.
- Active bacterial, viral, fungal, rickettsial, or parasitic infections receiving systemic anti-infective therapy (unless treated and resolved prior to the administration of the study drug)
- Live virus vaccines administered within 30 days prior to the first dose of the study drug. The use of inactivated seasonal influenza vaccines or approved COVID-19 vaccines is permitted, provided that the interval between vaccination and the first dose of the study drug is more than 1 week.
- Receiving immunology-based therapy for any reason
- Pregnant or lactating female patients.
- Any other diseases, clinically significant laboratory parameter abnormalities, severe medical or psychiatric illnesses/conditions, or substance abuse including alcoholism that, in the investigator's judgment, may compromise patient safety, study integrity, affect patient participation in the study, or interfere with the study objectives and outcome analysis.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Institutional Review Board of SYSUCC, 020-87343009, llwyh@sysucc.org.cn
About this study
This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.
- Being tested
- Drug Combination Therapy
- Keywords
- R/M HNSCC, Second-line therapy, Immune Checkpoint Inhibitors, Salvage 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.
Drug Combination TherapyDrug
Also called Docetaxel, Nimotuzumab, Pucotenlimab
[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, for 4-6 cycles (exact number determined by investigator assessment).
Maintenance Regimen: [Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, until protocol-defined treatment endpoints are reached.
Maintenance Therapy Eligibility: Subjects who meet both criteria after the last induction cycle: No disease progression confirmed by imaging and investigator assessment, and/or absence of intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | This single-arm phase II study evaluates the efficacy and safety of docetaxel, nimotuzumab, and pucotenlimab combination therapy as second- or later-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy. All enrolled patients must have unresectable, radiotherapy-ineligible R/M HNSCC, and ≤2 prior lines of therapy. Following screening and informed consent, treatment endpoints are defined from first dose until disease progression, death, intolerable toxicity, consent withdrawal, new anti-tumor therapy initiation, or other protocol-specified discontinuation criteria. Receives: Drug: Drug Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Imaging assessment after completion of the first 4-6 cycles of therapy (i.e.,at12-18weeks)
Secondary outcomes (7)
For CPS ≥20 and the Overall Population: Median Overall Survival (mOS)
mOS is defined as the time from from Day 1 of treatment initiation until death from any cause. mOS corresponds to the time point at which the Kaplan-Meier curve of overall survival probability reaches 50%, estimated using non-parametric interpolation. This endpoint will be analyzed in months.
Measured: At least up to 24 months.
For CPS ≥20 and the Overall Population: Median Progression-Free Survival (mPFS)
mPFS is defined as the time from Day 1 of treatment initiation until the first occurrence of disease progression (per RECIST v1.1), or death from any cause. mPFS corresponds to the time point at which the Kaplan-Meier curve of progression-free survival probability reaches 50%, estimated using non-parametric interpolation. This endpoint will be analyzed in months.
Measured: At least up to 24 months.
PFS rates at 6 and 12 months
PFS is defined as the time from the day of first study drug administration to tumor progression (in any aspect) or death (from any cause). PFS rates at 6 months and 12 months will be recorded separately.
Measured: PFS rates at 6 months and 12 months will be recorded separately.
Duration of Response (DoR)
Defined as the time interval from the first documented complete response (CR) or partial response (PR) per RECIST v1.1 criteria until disease progression or death (whichever occurs earlier). Units are days or months (e.g.,days or months).
Measured: At least up to 24 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Throughout this study and during the follow-up period, the severity of adverse events will be graded according to NCI-CTCAE v5.0. Safety evaluation metrics include:
Incidence, severity, and relationship to the study drug of:
All Adverse Events (AE) Treatment-Emergent Adverse Events (TEAE) Serious Adverse Events (SAE) Immune-Related Adverse Events (irAE).
Measured: At least up to 24 months.
Quality of Life (QoL)
The QoL was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), Version 3.0, which represent functions, symptoms, or health conditions. The EORTC QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Measured: Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment.
Psychological Scales Assessment as assessed by the Depression, Anxiety, and Stress Scale (DASS-21)
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluationoflife, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non specific arousal.
Recommended cut-off scores for conventional severity labels（normal,moderate,severe) are as follows: NB Scores on the DASS-21 will need to be multiplied by 2 to caculate the final score:
Depresslon: normal:0-9, mild:10-13, moderate:14-20, severe: 21-27, extremely severe: 28+.
Anxlety: normal:0-7, mild: 8-9, moderate:10-14, severe: 15-19, extremely severe: 20+.
Stress: normal: 0-14, mild: 15-18, moderate:19-25, severe: 26-33, extremely severe:34+.
Measured: Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd., Lepu Biopharma Co., Ltd.
- Responsible party
- Principal investigator, Chen Chunyan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354984
- Sponsor's protocol ID
- 2025-FXY-390
- Acronym
- PIONEER-HN
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07354984
- Acronym / sponsor ID
- PIONEER-HN / 2025-FXY-390
- Keywords
- R/M HNSCC, Second-line therapy, Immune Checkpoint Inhibitors, Salvage Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd., Lepu Biopharma Co., Ltd.
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Jan 2026 (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 II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Drug Combination TherapyThis single-arm phase II study evaluates the efficacy and safety of docetaxel, nimotuzumab, and pucotenlimab combination therapy as second- or later-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy. All enrolled patients must have unresectable, radiotherapy-ineligible R/M HNSCC, and ≤2 prior lines of therapy. Following screening and informed consent, treatment endpoints are defined from first dose until disease progression, death, intolerable toxicity, consent withdrawal, new anti-tumor therapy initiation, or other protocol-specified discontinuation criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with no deterioration within 2 weeks prior to enrollment.
- Age ≥ 18 years and ≤ 75 years
- Patients with pathologically and/or radiologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx and larynx), who have previously failed treatment with PD-1 (L1) inhibitors and platinum-based drugs. The two types of drugs could be administered as a first-line combination regimen or sequential therapy, with the number of prior treatment lines not exceeding two. If disease progression occurs during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy, or within 6 months after the discontinuation of such treatment, the medications used during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy (including platinum-based drugs, anti-EGFR monoclonal antibodies, PD-1 (L1) inhibitors, etc.) shall be regarded as first-line treatment. Discontinuation or dose reduction of one drug during treatment, or replacement of platinum-based drugs, fluorouracil-based drugs or PD-1 (L1) inhibitors without disease progression shall be counted as the same line of treatment.
- At least one radiologically measurable lesion according to RECIST v1.1
- Assessed by the investigator as not amenable to local therapy (e.g., surgery ± radiotherapy)
Key exclusion criteria (18 listed)
- A history of malignant tumor is known.
- Residual toxic reactions caused by prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc.) (excluding alopecia, fatigue and grade 2 hypothyroidism), or clinically significant laboratory test abnormalities > grade 1 (CTCAE v5.0)
- Known to have active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate in the study, provided that their disease is stable.
- A history of severe hypersensitivity reactions to taxanes or other monoclonal antibodies.
- Has any contraindication to the study drugs of this project (docetaxel, nimotuzumab, and camrelizumab)
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 |
|---|---|---|
| Drug Combination TherapyAlso: Docetaxel, Nimotuzumab, Pucotenlimab[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, for 4-6 cycles (exact number determined by investigator assessment). Maintenance Regimen: [Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, until protocol-defined treatment endpoints are reached. Maintenance Therapy Eligibility: Subjects who meet both criteria after the last induction cycle: No disease progression confirmed by imaging and investigator assessment, and/or absence of intolerable toxicity. | Drug | Treatment arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: Imaging assessment after completion of the first 4-6 cycles of therapy (i.e.,at12-18weeks)
7 secondary outcomes
For CPS ≥20 and the Overall Population: Median Overall Survival (mOS)
Time frame: At least up to 24 months.
For CPS ≥20 and the Overall Population: Median Progression-Free Survival (mPFS)
Time frame: At least up to 24 months.
PFS rates at 6 and 12 months
Time frame: PFS rates at 6 months and 12 months will be recorded separately.
Duration of Response (DoR)
Time frame: At least up to 24 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: At least up to 24 months.
Quality of Life (QoL)
Time frame: Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment.
Psychological Scales Assessment as assessed by the Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment.
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 21 Jan 2026.
- 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 Drug Combination Therapy in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Sun Yat-sen 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 9 inclusion and 18 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 21 Jan 2026. 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 Chun-Yan Chen, Prof. (020-87342926, chenchuny@sysucc.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 (ORR) (time frame: Imaging assessment after completion of the first 4-6 cycles of therapy (i.e.,at12-18weeks)). 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 21 Jan 2026.