Oral Squamous Cell Carcinoma (OSCC)Phase 2OSCCNCT07079410
Neoadjuvant and Adjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Sintilimab+Cetuximab in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma, Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Sintilimab+Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Oct 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
- Participants must have histologically or cytologically confirmed oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) >1
- Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET/CT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+/- chemotherapy.
- Age ranges from 18 to 75 years old
- ECOG performance status 0 or 1.
- Expected survival ≥ 3 months.
- Participants must have not received treatment for before.
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- There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.
- The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and/or confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 ^ 9/L; Neutrophil count (NEUT) ≥ 1.5 × 10 ^ 9/L, platelet count (PLT) ≥ 100 × 10 ^ 9/L, hemoglobin (Hb) ≥ 90 g/L; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
- The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Squamous cell carcinoma with primary site of nasopharynx or skin.
- Diagnosed with malignant diseases other than head and neck squamous cell carcinoma within 3 years before the first administration (excluding Radical treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative excised carcinoma in situ)
- Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
- Has received live or attenuated vaccines within 30 days prior to the first dose of Sintilimab, inactivated vaccines are allowed.
- Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.
- Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen [HBsAg]) or known history of active hepatitis C virus (defined as detection of HCV RNA [qualitative]) infection; Has a known history of human immunodeficiency virus (HIV) infection.
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- Has received allogeneic tissue/solid organ transplantation.
- Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2) with the exception of alopecia.
- Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。
- Has severe clinical infection (>NCI-CTCAE 5.0 Level 2 infection);
- Has uncontrollable hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.
- Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has participated in other clinical studies within 30 days prior to enrollment.
- Other situations that researchers consider unsuitable for participation in the study.
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
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Tong Ji, PhD, 86-13651658767, ji.tong@zs-hospital.sh.cn
About this study
Official title: A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma.
Read the detailed description
Approximately 60% of patients with oral/oropharyngeal squamous cell carcinoma (OSCC) are found to be in the local advanced stage. Even if they actively undergo comprehensive sequential treatment such as surgery, radiotherapy, and chemotherapy, the 5-year survival rate is still less than 50%. According to both the NCCN and the CSCO head and neck cancer treatment guidelines, radical surgery is the main treatment strategy for locally advanced OSCC, and adjuvant radiotherapy or chemotherapy/radiotherapy. However, the high treatment failure rate and disease recurrence rate are still the fundamental reasons for its poor prognosis. In recent years, neoadjuvant therapy has been proven to reduce the burden of local diseases in multiple tumor types, thereby improving surgical outcomes, reducing the risk of distant metastasis, and predicting prognosis based on the patient's pathological response. The combination of anti-PD-1/PD-L1 monoclonal antibody and EGFR monoclonal antibody has a synergistic anti-tumor effect. Multiple prospective studies have shown that the combination of cetuximab and anti-PD-1 monoclonal antibody has achieved good efficacy in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. The combination of neoadjuvant immunotherapy and EGFR monoclonal antibody therapy for locally advanced OSCC is worth exploring. This prospective, open label, single arm, phase II single center interventional study aims to evaluate the efficacy and safety of the neoadjuvant and adjunvant combination therapy of Sintilimab (anti-PD-1 monoclonal antibody) and cetuximab in patients with locally advanced OSCC.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma, Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Sintilimab+Cetuximab
- Keywords
- locally advanced OSCC
- 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.
Sintilimab+CetuximabDrug
Neoadjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week/cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week cycle, a total of 17 cycle) for a total of one year.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment + Surgery + Adjuvant Treatment | Experimental | Neoadjuvant Treatment + Surgery + Adjuvant Treatment Neoadjuvant treatment: The participants will receive 2 cycles of combination therapy (Sintilimab, Cetuximab). surgery: Primary tumor resection and/or lymph node dissection surgery 3 weeks from cycle 2 day 1. Adjuvant treatment: 3-8 weeks post-surgery and up to a total of one year. The participants will receive Sintilimab (q3w) therapy. Interventions: Drug: Sintilimab, Cetuximab Receives: Drug: Sintilimab+Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Pathological Response (mPR)
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
Measured: 2 months
Secondary outcomes (4)
Rate of Pathologic complete response (pCR)
Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.
Measured: 2 months
2 year Event-free Survival (EFS) Rate
EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1
Measured: 24 months
2 year Overall Survival (OS) Rate
OS is the time from study entry to death due to any cause
Measured: 24 months
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079410
- Sponsor's protocol ID
- B2025-287R
- Acronym
- OSCC
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07079410
- Acronym / sponsor ID
- OSCC / B2025-287R
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma, Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
- Keywords
- locally advanced OSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 23 Jul 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.
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma.
Detailed description
Approximately 60% of patients with oral/oropharyngeal squamous cell carcinoma (OSCC) are found to be in the local advanced stage. Even if they actively undergo comprehensive sequential treatment such as surgery, radiotherapy, and chemotherapy, the 5-year survival rate is still less than 50%. According to both the NCCN and the CSCO head and neck cancer treatment guidelines, radical surgery is the main treatment strategy for locally advanced OSCC, and adjuvant radiotherapy or chemotherapy/radiotherapy. However, the high treatment failure rate and disease recurrence rate are still the fundamental reasons for its poor prognosis. In recent years, neoadjuvant therapy has been proven to reduce the burden of local diseases in multiple tumor types, thereby improving surgical outcomes, reducing the risk of distant metastasis, and predicting prognosis based on the patient's pathological response. The combination of anti-PD-1/PD-L1 monoclonal antibody and EGFR monoclonal antibody has a synergistic anti-tumor effect. Multiple prospective studies have shown that the combination of cetuximab and anti-PD-1 monoclonal antibody has achieved good efficacy in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. The combination of neoadjuvant immunotherapy and EGFR monoclonal antibody therapy for locally advanced OSCC is worth exploring. This prospective, open label, single arm, phase II single center interventional study aims to evaluate the efficacy and safety of the neoadjuvant and adjunvant combination therapy of Sintilimab (anti-PD-1 monoclonal antibody) and cetuximab in patients with locally advanced OSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment + Surgery + Adjuvant Treatment | Experimental | Drug: Sintilimab+CetuximabNeoadjuvant Treatment + Surgery + Adjuvant Treatment Neoadjuvant treatment: The participants will receive 2 cycles of combination therapy (Sintilimab, Cetuximab). surgery: Primary tumor resection and/or lymph node dissection surgery 3 weeks from cycle 2 day 1. Adjuvant treatment: 3-8 weeks post-surgery and up to a total of one year. The participants will receive Sintilimab (q3w) therapy. Interventions: Drug: Sintilimab, Cetuximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have histologically or cytologically confirmed oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) >1
- Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET/CT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+/- chemotherapy.
- Age ranges from 18 to 75 years old
- ECOG performance status 0 or 1.
- Expected survival ≥ 3 months.
Key exclusion criteria (15 listed)
- Squamous cell carcinoma with primary site of nasopharynx or skin.
- Diagnosed with malignant diseases other than head and neck squamous cell carcinoma within 3 years before the first administration (excluding Radical treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative excised carcinoma in situ)
- Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
- Has received live or attenuated vaccines within 30 days prior to the first dose of Sintilimab, inactivated vaccines are allowed.
- Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.
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+CetuximabNeoadjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week/cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week cycle, a total of 17 cycle) for a total of one year. | Drug | Neoadjuvant Treatment + Surgery + Adjuvant Treatment |
Primary outcome
Rate of Major Pathological Response (mPR)
Time frame: 2 months
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
4 secondary outcomes
Rate of Pathologic complete response (pCR)
Time frame: 2 months
2 year Event-free Survival (EFS) Rate
Time frame: 24 months
2 year Overall Survival (OS) Rate
Time frame: 24 months
Adverse Events (AEs)
Time frame: 24 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 23 Jul 2025.
- 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 Sintilimab+Cetuximab in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma, run by Shanghai Zhongshan 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 11 inclusion and 15 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 23 Jul 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 Tong Ji, PhD (86-13651658767, ji.tong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Pathological Response (mPR) (time frame: 2 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 23 Jul 2025.