Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)Phase 2NCT07310771
Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II
A Phase 2 study testing Sintilimab combined with chemotherapy and nimotuzumab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN), run by Fujian Cancer Hospital.
Trial summary
Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R/M-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)
- What is being tested?
- Sintilimab combined with chemotherapy and nimotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 10 Jul 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
- Provision of written informed consent, with full understanding of and agreement to comply with study requirements and the visit schedule.
- Age 18-75 years (inclusive) at the time of informed consent; either sex.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator.
- Documented EGFR-positive tumor.
- No prior systemic therapy for head and neck squamous cell carcinoma.
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- At least one measurable lesion per RECIST v1.1.
- Estimated life expectancy ≥ 12 weeks.
- Adequate bone-marrow and organ function.
Who cannot join
- Known hypersensitivity to any component of PD(L)-1 inhibitors, paclitaxel, or cisplatin.
- Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for >5 years).
- Uncontrolled cardiac symptoms or clinically significant cardiac disease.
- Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration.
- Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose.
- Severe infection (> CTCAE Grade 2) within 4 weeks before first study dose.
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- Active autoimmune disease or documented autoimmune-disease history requiring systemic therapy.
- History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency syndromes, or prior solid-organ or allogeneic bone-marrow transplantation.
- History of interstitial lung disease or non-infectious pneumonitis.
- Evidence of active tuberculosis infection on history or CT imaging.
- Active hepatitis B (HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL).
- History of substance abuse, alcohol abuse, or drug addiction.
- Pregnant or lactating women.
- Any condition that, in the investigator's opinion, could necessitate premature withdrawal from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Phase II Study of Sintilimab Plus Nimotuzumab and Chemotherapy Followed by Definitive Chemoradiotherapy With Nimotuzumab for Locally Advanced Head and Neck Squamous Cell Carcinoma
Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R/M-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Incremental improvements in efficacy are still required, necessitating the development of more effective regimens. Whether combining an ICI with chemotherapy and nimotuzumab can confer additional clinical benefit in LA-SCCHN remains to be determined. Against this backdrop, we designed a single-arm, phase II, single-centre clinical trial to evaluate the efficacy and safety of sintilimab plus chemotherapy and nimotuzumab for patients with LA-SCCHN.
- Being tested
- Sintilimab combined with chemotherapy and nimotuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab combined with chemotherapy and nimotuzumabDrug
The study plans to enroll patients with locally advanced squamous cell carcinoma of the head and neck. After induction with sintilimab plus paclitaxel, cisplatin, and nimotuzumab, participants will receive concurrent chemoradiotherapy with nimotuzumab, followed by maintenance sintilimab monotherapy until disease progression, unacceptable toxicity, death, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab combined with chemotherapy and nimotuzumab for patients with LA-SCCHN | Experimental | Not described Receives: Drug: Sintilimab combined with chemotherapy and nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Larynx-preservation rate at 3 months post-radiotherapy
Measured: 3 months
Secondary outcomes (9)
objective response rate
Measured: 24 months
One-year progression-free survival (PFS) rates
Measured: 12 months
Two-year progression-free survival (PFS) rates
Measured: 24 months
One-year loco-regional relapse-free survival (LRFS) rates.
Measured: 12 months
two-year loco-regional relapse-free survival (LRFS) rates.
Measured: 24 months
One- year distant-metastasis-free survival (DMFS) rates.
Measured: 12 months
two-year distant-metastasis-free survival (DMFS) rates
Measured: 24 months
One-year larynx-preservation rates
Measured: 12 months
AE/SAE
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)Studies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310771
- Sponsor's protocol ID
- K2025-193-01
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Study of Sintilimab Plus Nimotuzumab and Chemotherapy Followed by Definitive Chemoradiotherapy With Nimotuzumab for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07310771
- Acronym / sponsor ID
- K2025-193-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2029 (estimated)
- First posted
- 30 Dec 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.
Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R/M-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Incremental improvements in efficacy are still required, necessitating the development of more effective regimens. Whether combining an ICI with chemotherapy and nimotuzumab can confer additional clinical benefit in LA-SCCHN remains to be determined. Against this backdrop, we designed a single-arm, phase II, single-centre clinical trial to evaluate the efficacy and safety of sintilimab plus chemotherapy and nimotuzumab for patients with LA-SCCHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab combined with chemotherapy and nimotuzumab for patients with LA-SCCHN | Experimental | Drug: Sintilimab combined with chemotherapy and nimotuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of written informed consent, with full understanding of and agreement to comply with study requirements and the visit schedule.
- Age 18-75 years (inclusive) at the time of informed consent; either sex.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator.
- Documented EGFR-positive tumor.
Key exclusion criteria (14 listed)
- Known hypersensitivity to any component of PD(L)-1 inhibitors, paclitaxel, or cisplatin.
- Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for >5 years).
- Uncontrolled cardiac symptoms or clinically significant cardiac disease.
- Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration.
- Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose.
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 |
|---|---|---|
| Sintilimab combined with chemotherapy and nimotuzumabThe study plans to enroll patients with locally advanced squamous cell carcinoma of the head and neck. After induction with sintilimab plus paclitaxel, cisplatin, and nimotuzumab, participants will receive concurrent chemoradiotherapy with nimotuzumab, followed by maintenance sintilimab monotherapy until disease progression, unacceptable toxicity, death, or withdrawal of consent. | Drug | Sintilimab combined with chemotherapy and nimotuzumab for patients with LA-SCCHN |
Primary outcome
Larynx-preservation rate at 3 months post-radiotherapy
Time frame: 3 months
9 secondary outcomes
objective response rate
Time frame: 24 months
One-year progression-free survival (PFS) rates
Time frame: 12 months
Two-year progression-free survival (PFS) rates
Time frame: 24 months
One-year loco-regional relapse-free survival (LRFS) rates.
Time frame: 12 months
two-year loco-regional relapse-free survival (LRFS) rates.
Time frame: 24 months
One- year distant-metastasis-free survival (DMFS) rates.
Time frame: 12 months
two-year distant-metastasis-free survival (DMFS) rates
Time frame: 24 months
One-year larynx-preservation rates
Time frame: 12 months
AE/SAE
Time frame: 42 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 30 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)
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HNSCC
RecruitingPhase 2
Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck
Locally Advanced Head and Neck Squamous Cell Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab combined with chemotherapy and nimotuzumab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN), run by Fujian Cancer Hospital.
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 14 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 30 Dec 2025. 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?
Contact Yun Xu (+86 136 0088 3867, 308466040@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Larynx-preservation rate at 3 months post-radiotherapy (time frame: 3 months). 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 Dec 2025.