Head and Neck Squamous Cell Carcinoma HNSCCPhase 2NCT07751276
Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC
A Phase 2 study testing Neoadjuvant Finotonlimab Plus Chemotherapy, Surgery and Postoperative Finotonlimab Maintenance in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Yanjie Zhang, MD.
Trial summary
This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced… 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 HNSCC
- What is being tested?
- Neoadjuvant Finotonlimab Plus Chemotherapy, Surgery and Postoperative Finotonlimab Maintenance
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2032
- 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
- Age 18-75 years
- Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
- Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable
- ECOG sccore 0-1
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor
- Willing to undergo surgical treatment
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- No significant contraindications to immunotherapy, radiotherapy, or chemotherapy
- Major organ function meets the following criteria: a) Hematologic: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L (no blood transfusion or blood products, no G-CSF or other hematopoietic growth factors within 14 days); b) Biochemistry: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) Adequate coagulation: defined as INR or PT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, PT within the intended therapeutic range of the anticoagulant is acceptable
- Both male and female subjects are eligible; women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody
- The subject voluntarily enrolls in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up
Who cannot join
- Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
- Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
- Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies
- Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure
- Receipt of a live vaccine within 4 weeks prior to the first dose of study drug; inactivated influenza vaccine administered by injection is permitted, while intranasal live attenuated influenza vaccine is not permitted
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- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Known history of psychotropic substance abuse or drug addiction
- Pregnant or lactating women
- Diagnosis of any other malignancy within 5 years prior to study entry, except for curatively treated localized cancers including basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma
- Any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for study participation in the opinion of the investigator
About this study
Official title: A Multicenter, Randomized Controlled Clinical Trial of Finotonlimab Combined With Chemotherapy as Perioperative Therapy for Untreated Stage II Head and Neck Squamous Cell Carcinoma
This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
- Being tested
- Neoadjuvant Finotonlimab Plus Chemotherapy, Surgery, Postoperative Finotonlimab Maintenance
- Keywords
- Stage II Head and Neck Squamous Cell Carcinoma, Neoadjuvant Chemoimmunotherapy, Anti-PD-1 Therapy, Finotonlimab
- 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.
Neoadjuvant Finotonlimab Plus ChemotherapyDrug
Participants receive neoadjuvant finotonlimab 200 mg intravenously on Day 1, albumin-bound paclitaxel 100 mg/m² intravenously on Days 1, 8, and 15, and carboplatin at an area under the concentration-time curve of 4 intravenously on Day 1 of each 21-day cycle for 2 cycles before surgery. Cisplatin 75 mg/m² intravenously on Day 1 may be substituted for carboplatin.
SurgeryProcedure or surgery
Participants undergo definitive surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be administered according to postoperative pathological risk factors.
Postoperative Finotonlimab MaintenanceDrug
Participants receive postoperative finotonlimab 200 mg intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Treatment begins 3 to 6 weeks after surgery or, for participants receiving postoperative radiotherapy or concurrent chemoradiotherapy, within 2 weeks after completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Upfront Surgery | Active comparator | Participants undergo upfront surgery. Based on postoperative pathological risk factors, participants may receive postoperative radiotherapy or concurrent chemoradiotherapy. Receives: Procedure: Surgery |
| Neoadjuvant Finotonlimab Plus Chemotherapy | Experimental | Participants receive two 3-week cycles of neoadjuvant finotonlimab plus nab-paclitaxel and carboplatin or cisplatin, followed by surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be given based on pathological risk factors. Participants also receive six 3-week cycles of postoperative finotonlimab maintenance therapy. Receives: Drug: Neoadjuvant Finotonlimab Plus Chemotherapy; Procedure: Surgery; Drug: Postoperative Finotonlimab Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
Measured: 2 years after randomization
Secondary outcomes (10)
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive. OS will be estimated using the Kaplan-Meier method. The planned primary OS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
Measured: 2 years after randomization
Major Pathological Response (MPR) Rate
The proportion of participants in the experimental-arm intention-to-treat population who achieve a major pathological response. MPR is defined as 10% or less residual viable tumor in the resected primary tumor and sampled regional lymph nodes, calculated as the area of residual viable tumor divided by the total tumor bed area.
Measured: Within 2 weeks after surgery
Pathologic Complete Response (pCR) Rate
The proportion of participants in the experimental-arm intention-to-treat population who achieve a pathologic complete response. pCR is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes.
Measured: Within 2 weeks after surgery
5-Year Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive or at 5 years after randomization, whichever occurs first. OS will be estimated using the Kaplan-Meier method.
Measured: 5 years after randomization
5-Year Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment or at 5 years after randomization, whichever occurs first. EFS will be estimated using the KaplanMeier method.
Measured: 5 years after randomization
2-Year Distant Metastasis-Free Survival (DMFS)
Distant metastasis-free survival (DMFS) is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Participants who remain alive and distant metastasis-free will be censored at the date of the last adequate disease assessment. DMFS will be estimated using the Kaplan-Meier method.
Measured: 2 years after randomization
5-Year Distant Metastasis-Free Survival (DMFS)
Distant metastasis-free survival (DMFS) is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Participants who remain alive and distant metastasis-free will be censored at the date of the last adequate disease assessment. DMFS will be estimated using the Kaplan-Meier method.
Measured: 5 years after randomization
2-Year Locoregional Recurrence-Free Survival (LRFS)
Locoregional recurrence-free survival (LRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first. Participants who remain alive and free of locoregional recurrence will be censored at the date of the last adequate disease assessment. LRFS will be estimated using the Kaplan-Meier method.
Measured: 2 years after randomization
5-Year Locoregional Recurrence-Free Survival (LRFS)
Locoregional recurrence-free survival (LRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first. Participants who remain alive and free of locoregional recurrence will be censored at the date of the last adequate disease assessment. LRFS will be estimated using the Kaplan-Meier method.
Measured: 5 years after randomization
Incidence of Adverse Events
The number and proportion of participants who experience adverse events, serious adverse events, Grade 3 or higher adverse events, treatment-related adverse events, and adverse events leading to treatment modification or discontinuation. Adverse events will be coded using MedDRA version 25.0 by preferred term and system organ class. Treatment-emergent adverse events are defined as adverse events occurring after initiation of the assigned study treatment.
Measured: From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (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 Carcinoma 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanjie Zhang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanjie Zhang, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751276
- Sponsor's protocol ID
- SH9H-2026-T337-3
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Trial of Finotonlimab Combined With Chemotherapy as Perioperative Therapy for Untreated Stage II Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07751276
- Acronym / sponsor ID
- SH9H-2026-T337-3
- Keywords
- Stage II Head and Neck Squamous Cell Carcinoma, Neoadjuvant Chemoimmunotherapy, Anti-PD-1 Therapy, Finotonlimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Yanjie Zhang, MDUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 7 Aug 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 multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Surgery | Active comparator | Procedure: SurgeryParticipants undergo upfront surgery. Based on postoperative pathological risk factors, participants may receive postoperative radiotherapy or concurrent chemoradiotherapy. |
| Neoadjuvant Finotonlimab Plus Chemotherapy | Experimental | Drug: Neoadjuvant Finotonlimab Plus Chemotherapy, Procedure: Surgery, Drug: Postoperative Finotonlimab MaintenanceParticipants receive two 3-week cycles of neoadjuvant finotonlimab plus nab-paclitaxel and carboplatin or cisplatin, followed by surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be given based on pathological risk factors. Participants also receive six 3-week cycles of postoperative finotonlimab maintenance therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years
- Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
- Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable
- ECOG sccore 0-1
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor
Key exclusion criteria (11 listed)
- Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
- Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
- Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies
- Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure
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 |
|---|---|---|
| Neoadjuvant Finotonlimab Plus ChemotherapyParticipants receive neoadjuvant finotonlimab 200 mg intravenously on Day 1, albumin-bound paclitaxel 100 mg/m² intravenously on Days 1, 8, and 15, and carboplatin at an area under the concentration-time curve of 4 intravenously on Day 1 of each 21-day cycle for 2 cycles before surgery. Cisplatin 75 mg/m² intravenously on Day 1 may be substituted for carboplatin. | Drug | Neoadjuvant Finotonlimab Plus Chemotherapy |
| SurgeryParticipants undergo definitive surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be administered according to postoperative pathological risk factors. | Procedure or surgery | Neoadjuvant Finotonlimab Plus Chemotherapy, Upfront Surgery |
| Postoperative Finotonlimab MaintenanceParticipants receive postoperative finotonlimab 200 mg intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Treatment begins 3 to 6 weeks after surgery or, for participants receiving postoperative radiotherapy or concurrent chemoradiotherapy, within 2 weeks after completion of radiotherapy. | Drug | Neoadjuvant Finotonlimab Plus Chemotherapy |
Primary outcome
Event-Free Survival (EFS)
Time frame: 2 years after randomization
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
10 secondary outcomes
Overall Survival (OS)
Time frame: 2 years after randomization
Major Pathological Response (MPR) Rate
Time frame: Within 2 weeks after surgery
Pathologic Complete Response (pCR) Rate
Time frame: Within 2 weeks after surgery
5-Year Overall Survival (OS)
Time frame: 5 years after randomization
5-Year Event-Free Survival (EFS)
Time frame: 5 years after randomization
2-Year Distant Metastasis-Free Survival (DMFS)
Time frame: 2 years after randomization
5-Year Distant Metastasis-Free Survival (DMFS)
Time frame: 5 years after randomization
2-Year Locoregional Recurrence-Free Survival (LRFS)
Time frame: 2 years after randomization
5-Year Locoregional Recurrence-Free Survival (LRFS)
Time frame: 5 years after randomization
Incidence of Adverse Events
Time frame: From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.
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 7 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Finotonlimab Plus Chemotherapy, Surgery and Postoperative Finotonlimab Maintenance in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Yanjie Zhang, MD.
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 10 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Event-Free Survival (EFS) (time frame: 2 years after randomization). 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 7 Aug 2026.