Head and Neck Squamous Cell CarcinomaPhase 2NCT06081673
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
A Phase 2 study testing Penpulimab injection, cisplatin and albumin-paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Penpulimab injection, cisplatin and albumin-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to 30 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
- Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
- Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.
Who cannot join
- Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
- Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
- A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
- Abnormal function of major organs
- Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Penpulimab injection, cisplatin, albumin-paclitaxel
- 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.
Penpulimab injectionDrug
Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2)； 200mg,D1, IV(21 days/cycle).
cisplatinDrug
Cisplatin :75mg/m2, D1, IV(21 days/cycle)
albumin-paclitaxelDrug
albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)
| Study group | Role | What they receive |
|---|---|---|
| Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy | Experimental | Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle.
Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab).
Non-MPR patients receive standard adjuvant therapy Receives: Drug: Penpulimab injection; Drug: cisplatin; Drug: albumin-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response（MPR）
Major pathologic response is based on the pathological examination on the post-operative specimens.
Measured: One year
Secondary outcomes (8)
Disease-control Rate（DCR）
The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).
Measured: Baseline up to 3 years.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 3 years.
Disease-free survival at 2 years(DFS at 2 years)
The proportion of subjects disease-free survival at 2 years
Measured: Baseline up to 2 years.
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Measured: Baseline up to 3 years.
Local recurrence-free survival at 2years(LRFS at 2 years)
The proportion of subjects local recurrence-free survival at 2years
Measured: Baseline up to 2 years.
distant metastasis-free survival at 2 years(DMFS at 2 years)
The proportion of subjects distant metastasis-free survival at 2years
Measured: Baseline up to 2 years.
OS at 2 years
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
Measured: Baseline up to 2 years.
pathologic complete response(pCR)
Pathological examination showed the presence of 0% active tumor in the tissue specimen
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start17 Oct 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Oct 2027 (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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081673
- Sponsor's protocol ID
- ALTER-HN001
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06081673
- Acronym / sponsor ID
- ALTER-HN001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 13 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 aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy | Experimental | Drug: Penpulimab injection, Drug: cisplatin, Drug: albumin-paclitaxelPenpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle. Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab). Non-MPR patients receive standard adjuvant therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
- Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
- Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.
Key exclusion criteria (6 listed)
- Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
- Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
- A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
- Abnormal function of major organs
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 |
|---|---|---|
| Penpulimab injectionPenpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2)； 200mg,D1, IV(21 days/cycle). | Drug | Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy |
| cisplatinCisplatin :75mg/m2, D1, IV(21 days/cycle) | Drug | Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy |
| albumin-paclitaxelalbumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle) | Drug | Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy |
Primary outcome
Major pathological response（MPR）
Time frame: One year
Major pathologic response is based on the pathological examination on the post-operative specimens.
8 secondary outcomes
Disease-control Rate（DCR）
Time frame: Baseline up to 3 years.
Adverse event rate
Time frame: Baseline up to 3 years.
Disease-free survival at 2 years(DFS at 2 years)
Time frame: Baseline up to 2 years.
Overall Response Rate (ORR)
Time frame: Baseline up to 3 years.
Local recurrence-free survival at 2years(LRFS at 2 years)
Time frame: Baseline up to 2 years.
distant metastasis-free survival at 2 years(DMFS at 2 years)
Time frame: Baseline up to 2 years.
OS at 2 years
Time frame: Baseline up to 2 years.
pathologic complete response(pCR)
Time frame: One year
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 30 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Penpulimab injection, cisplatin and albumin-paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response（MPR） (time frame: One year). 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 30 Sep 2026.