Oral CancerPhase 3NCT07402538
Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma
A Phase 3 study testing Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy and Surgery and postoperative radiotherapy or chemoradiotherapy in people with Oral Cancer and Oropharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cancer, Oropharyngeal Cancer
- What is being tested?
- Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy and Surgery and postoperative radiotherapy or chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 31 Dec 2030
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- Patients with concurrent other malignant tumors
- Patients with known or suspected autoimmune diseases, including dementia and epilepsy.
- Patients with severe mental disorders at the same time
- Patients with necrotic lesions who are assessed by the investigator as having a risk of massive hemorrhage
- Patients with severe heart disease or pulmonary dysfunction, and those with cardiac or pulmonary function grade ≤ 3 (grade 3 inclusive)
- Patients with laboratory test results that do not meet the relevant criteria within 7 days prior to enrollment
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- Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment
- Patients with comorbidities requiring long-term treatment with immunosuppressive drugs, or requiring systemic or local administration of corticosteroids at immunosuppressive doses.
- Patients with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- A history of prior use of anti-Tislelizumab, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways).
- Subjects with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or those whose childhood asthma has been completely relieved and who do not require any intervention in adulthood are eligible for enrollment; those with asthma requiring medical intervention with bronchodilators are not eligible for enrollment.
- HIV-positive subjects
- Positive for HBsAg with concurrent positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive for chronic hepatitis C on blood screening (HCV antibody positive)
- Received any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment
- Pregnant women with positive pregnancy test results among females of childbearing potential and lactating women.
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
Pu-Yun OuYang, M.D., 020-87342925, ouyangpy@sysucc.org.cn
Ming Song, M.D.
About this study
Official title: SBRT Followed by Neoadjuvant Chemoimmunotherapy Before Surgery in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma: a Randomized Controlled Phase III Trial
The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Being tested
- Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy, Surgery and postoperative radiotherapy or chemoradiotherapy
- Keywords
- SBRT, neoadjuvant therapy, locally advanced oral/oropharyngeal cancer
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapyCombination product
The patient was initially subjected to a neoadjuvant treatment regime, encompassing stereotactic body radiotherapy (SBRT) and chemoimmunotherapy. The SBRT was administered with a dose of 6 Gy per fraction to the primary tumour and metastatic lymph nodes, administered every other day for a total of three fractions. Following this, a period of one to two weeks was to elapse before the initiation of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²), on a three-week cycle, for a total of two cycles. A subsequent imaging re-examination was to be performed for assessment two weeks after the final chemotherapy cycle. Finally, curative surgical resection was to be performed 3-4 weeks after the final chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for two cycles.
Surgery and postoperative radiotherapy or chemoradiotherapyCombination product
Radical surgery followed by postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for three cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment followed by surgery arm | Experimental | Initially, the patient underwent neoadjuvant treatment, including stereotactic body radiotherapy (SBRT) followed by chemoimmunotherapy of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²). A subsequent imaging re-examination is to be performed for assessment two weeks after the last chemotherapy cycle. Finally, curative surgical resection should be performed 3-4 weeks after the last chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy. Receives: Combination Product: Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy |
| Surgery arm | Active comparator | Radical surgery followed by postoperative radiotherapy or chemoradiotherapy. Receives: Combination Product: Surgery and postoperative radiotherapy or chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival
The time interval from randomization to the occurrence of imaging tumor progression during the neoadjuvant treatment stage that makes surgery impossible, or postoperative imaging or biopsy results show local tumor recurrence, lymph node recurrence, distant metastasis, or death for any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years.
Secondary outcomes (7)
2-year overall survival
The time interval from random start to death for any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to two years.
MPR
Proportion of patients with ≤10% viable tumor cells identified per AJCC/CAP Tumor Regression Grading (TRG) protocol evaluation of surgical specimens.
Measured: Three weeks after surgery
pCR
Proportion of patients with no viable tumor cells identified upon complete and systematic evaluation of postoperative specimens under the AJCC/CAP Tumor Regression Grading (TRG) protocol, including microscopic examination of all sampled primary tumor sites and regional lymph nodes.
Measured: Three weeks after surgery
Mandibular Preservation Rate
Proportion of oral cancer patients retaining mandibular continuity after primary tumor resection.
Measured: On the day of surgery
Incidence rates of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Percentage of patients with adverse events ≥ Grade 3 among all treated patients.
Measured: Through study completion, an average of 3 year
Quality of life assessment
Quality of life was assessed using the EORTC QLQ-C30 scale at postoperative time point of 2 year.
Measured: Postoperatively at 24 months
Quality of life assessment
Quality of life was assessed using the QLQ-H\&N35 scale at postoperative time point of 2 year
Measured: Postoperatively at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
- Investigators
- Fang-Yun Xie, M.D., Principal investigator, Sun Yat-Sen University Cancer CenterMing Song, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402538
- Sponsor's protocol ID
- B2025-532-X01
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Followed by Neoadjuvant Chemoimmunotherapy Before Surgery in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma: a Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT07402538
- Acronym / sponsor ID
- B2025-532-X01
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Keywords
- SBRT, neoadjuvant therapy, locally advanced oral/oropharyngeal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Feb 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.
The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment followed by surgery arm | Experimental | Combination Product: Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapyInitially, the patient underwent neoadjuvant treatment, including stereotactic body radiotherapy (SBRT) followed by chemoimmunotherapy of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²). A subsequent imaging re-examination is to be performed for assessment two weeks after the last chemotherapy cycle. Finally, curative surgical resection should be performed 3-4 weeks after the last chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy. |
| Surgery arm | Active comparator | Combination Product: Surgery and postoperative radiotherapy or chemoradiotherapyRadical surgery followed by postoperative radiotherapy or chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Patients with concurrent other malignant tumors
- Patients with known or suspected autoimmune diseases, including dementia and epilepsy.
- Patients with severe mental disorders at the same time
- Patients with necrotic lesions who are assessed by the investigator as having a risk of massive hemorrhage
- Patients with severe heart disease or pulmonary dysfunction, and those with cardiac or pulmonary function grade ≤ 3 (grade 3 inclusive)
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 treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapyThe patient was initially subjected to a neoadjuvant treatment regime, encompassing stereotactic body radiotherapy (SBRT) and chemoimmunotherapy. The SBRT was administered with a dose of 6 Gy per fraction to the primary tumour and metastatic lymph nodes, administered every other day for a total of three fractions. Following this, a period of one to two weeks was to elapse before the initiation of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²), on a three-week cycle, for a total of two cycles. A subsequent imaging re-examination was to be performed for assessment two weeks after the final chemotherapy cycle. Finally, curative surgical resection was to be performed 3-4 weeks after the final chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for two cycles. | Combination product | Neoadjuvant treatment followed by surgery arm |
| Surgery and postoperative radiotherapy or chemoradiotherapyRadical surgery followed by postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for three cycles. | Combination product | Surgery arm |
Primary outcome
2-year event-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years.
The time interval from randomization to the occurrence of imaging tumor progression during the neoadjuvant treatment stage that makes surgery impossible, or postoperative imaging or biopsy results show local tumor recurrence, lymph node recurrence, distant metastasis, or death for any cause.
7 secondary outcomes
2-year overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to two years.
MPR
Time frame: Three weeks after surgery
pCR
Time frame: Three weeks after surgery
Mandibular Preservation Rate
Time frame: On the day of surgery
Incidence rates of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame: Through study completion, an average of 3 year
Quality of life assessment
Time frame: Postoperatively at 24 months
Quality of life assessment
Time frame: Postoperatively at 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 11 Feb 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.
Fang-Yun Xie, M.D. principal investigator
Sun Yat-Sen University Cancer Center
Ming Song, M.D. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy and Surgery and postoperative radiotherapy or chemoradiotherapy in people with Oral Cancer and Oropharyngeal Cancer, 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 0 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 11 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Pu-Yun OuYang, M.D. (020-87342925, ouyangpy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years.). 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 11 Feb 2026.