Oral Squamous Cell Carcinoma (OSCC)Phase 2NCT07778368
A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma
A Phase 2 study testing Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab, Radical Surgery for OSCC and Radiation Therapy in people with Oral Squamous Cell Carcinoma (OSCC), run by Shanghai East Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab, Radical Surgery for OSCC and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 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
- Ages 18-75 (inclusive); no gender restrictions.
- Histologically or cytologically confirmed locally advanced oral squamous cell carcinoma (AJCC 8th Edition stages III-IVA).
- Resectable and having not previously received any antitumor therapy for oral squamous cell carcinoma.
- At least one evaluable tumor lesion according to RECIST version 1.1.
- A tumor tissue specimen must be provided or a tumor biopsy must be performed prior to receiving neoadjuvant therapy for Trop-2 and PD-L1 immunohistochemical testing.
- ECOG performance status of 0-1.
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- Expected survival of 6 months or longer.
- Good bone marrow and organ function:
- Hematologic system (no blood transfusion or hematopoietic growth factor therapy within the past 14 days):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (2) Platelets (PLT) ≥ 100 × 10⁹/L (3) Hemoglobin (Hb) ≥ 9 g/L
- Liver function
- Total bilirubin (TBIL) ≤ 1.5 × ULN (2) Alanine aminotransferase (ALT) ≤ 3 × ULN (3) Aspartate aminotransferase (AST) ≤ 3×ULN
- Renal function
- Creatinine (Cr) ≤ 1.5×ULN
- Creatinine clearance (Ccr) (to be calculated only when creatinine > 1.5×ULN) > 50 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation function (applicable to patients not receiving anticoagulant therapy; for subjects receiving anticoagulant therapy, INR or APTT should be within the expected therapeutic range for the anticoagulant)
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
- International Normalized Ratio (INR) ≤ 1.5×ULN
- Eligible patients of reproductive potential (both men and women) must agree to use reliable contraception (such as hormonal, barrier, or abstinence methods) with their partners during the trial and for at least 6 months after the last dose of treatment; female patients of childbearing potential (as defined in Appendix 5) must have a negative blood or urine pregnancy test within 7 days prior to the first administration of the study drug.
- Subjects must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.
Who cannot join
- Presence of precancerous lesions such as oral leukoplakia, erythroplakia, or lichen planus.
- History of head and neck radiation therapy.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration of the study drug.
- Underwent major organ surgery (excluding needle biopsies and tracheotomies) or sustained significant trauma within 4 weeks prior to the first administration of the study drug.
- Received an attenuated live vaccine within 4 weeks prior to the first administration of the study drug.
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- Patients who have received, within 14 days prior to the first administration of the study drug, or who require long-term systemic administration of glucocorticoids (prednisone > 10 mg/day or an equivalent dose of a similar drug) or other immunosuppressants during the study; the following exceptions apply: treatment with topical, ophthalmic, intra-articular, intranasal, or inhaled glucocorticoids; and short-term use of glucocorticoids for prophylactic treatment (e.g., to prevent contrast medium allergy).
- Patients with active autoimmune diseases or a history of such diseases with a risk of recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid disease or type 1 diabetes.
- A history of other malignancies within 5 years prior to the first administration of the study drug, excluding tumors with negligible risk of metastasis or death, such as cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ of the breast.
- A history of immunodeficiency, including a positive HIV antibody test.
- Active infection currently requiring intravenous antimicrobial therapy.
- Active hepatitis B (HBsAg-positive and HBV-DNA > 500 IU/mL or the study site's lower limit of detection [only if the study site's lower limit of detection is higher than 500 IU/mL]), active hepatitis C (patients who are HCV-antibody-positive but have HCV-RNA < the study site's lower limit of detection are eligible for inclusion); patients receiving prophylactic antiviral therapy other than interferon are eligible for inclusion. For subjects who are HBsAg-positive but HBV-DNA-negative, prophylactic antiviral therapy other than interferon must be administered.
- Patients currently suffering from interstitial lung disease (excluding radiation-induced pulmonary fibrosis not requiring steroid therapy) or from pulmonary comorbidities resulting in clinically significant pulmonary dysfunction.
- Patients currently suffering from active inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- Patients with a history of severe cardiovascular or cerebrovascular disease, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention or second- or third-degree atrioventricular block; (2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular or cerebrovascular events of Grade 3 or higher occurring within 6 months prior to the first dose; (3) Heart failure classified as New York Heart Association (NYHA) Class II or higher, or a left ventricular ejection fraction (LVEF) < 50%, or other structural heart disease deemed high-risk by the investigator; (4) Clinically uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg despite treatment).
- 16. Known history of severe allergic reactions to macromolecular drugs. 17. Known alcohol or drug dependence. 18. Patients with psychiatric disorders or poor compliance. 19. Pregnant or breastfeeding women. 20. Patients with a history of other serious systemic diseases, or other reasons deemed by the investigator to make them unsuitable for participation in this clinical trial.
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
Shanghai East Hospital
Shanghai
Ye Guo, PhD, +8613501678472, pattrickguo@gmail.com
About this study
This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab, Radical Surgery for OSCC, Radiation Therapy, Cisplatin
- Keywords
- Oral Squamous Cell Carcinoma
- 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.
Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with ToripalimabDrug
Sacituzumab Govitecan(10 mg/kg, intravenous infusion, on Days 1 and 8) in combination with toripalimab (240 mg, intravenous infusion, on Day 1) every 3 weeks, for 2 cycles.
OR Sacituzumab Tirumotecan (5 mg/kg, intravenous infusion, on Day 1) in combination with toripalimab (3 mg/kg, intravenous infusion, on Day 1) every 2 weeks, for 3 cycles.
Radical Surgery for OSCCProcedure or surgery
If imaging studies following neoadjuvant therapy show a tumor response of PR or SD, or PD but the tumor is amenable to curative resection, surgery is performed.
Radiation TherapyRadiation
Participants will begin adjuvant radiation therapy 4-6 weeks after surgery. Radiation therapy will be administered using intensity-modulated radiation therapy (IMRT) at a dose of 66-70 Gy (investigators may adjust the dose appropriately based on the patient's actual condition).
CisplatinDrug
Participants with high-risk factors, such as extracapsular lymph node invasion or inadequate surgical margins, should receive concurrent cisplatin therapy (unless the investigator determines that the patient is not suitable for cisplatin treatment). The cisplatin regimen includes a 3-week schedule (100 mg/m², at least 2 cycles) or a weekly schedule (40 mg/m², at least 5 cycles), as determined by the investigator based on the patient's individual condition.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab; Procedure: Radical Surgery for OSCC; Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
Measured: in 4 weeks post surgery
Secondary outcomes (5)
Incidence and frequency of AEs and SAEs
Measured: From first dose to 30 days after the last dose of study drug.
pCR
Measured: in 4 weeks post surgery
ORR
Measured: 2 years post surgery
EFS
Measured: 2 years post surgery
OS
Measured: 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778368
- Sponsor's protocol ID
- 2026YS-173
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07778368
- Acronym / sponsor ID
- 2026YS-173
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Oral Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 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 study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab, Procedure: Radical Surgery for OSCC, Radiation: Radiation Therapy, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Ages 18-75 (inclusive); no gender restrictions.
- Histologically or cytologically confirmed locally advanced oral squamous cell carcinoma (AJCC 8th Edition stages III-IVA).
- Resectable and having not previously received any antitumor therapy for oral squamous cell carcinoma.
- At least one evaluable tumor lesion according to RECIST version 1.1.
- A tumor tissue specimen must be provided or a tumor biopsy must be performed prior to receiving neoadjuvant therapy for Trop-2 and PD-L1 immunohistochemical testing.
Key exclusion criteria (17 listed)
- Presence of precancerous lesions such as oral leukoplakia, erythroplakia, or lichen planus.
- History of head and neck radiation therapy.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration of the study drug.
- Underwent major organ surgery (excluding needle biopsies and tracheotomies) or sustained significant trauma within 4 weeks prior to the first administration of the study drug.
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 |
|---|---|---|
| Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with ToripalimabSacituzumab Govitecan(10 mg/kg, intravenous infusion, on Days 1 and 8) in combination with toripalimab (240 mg, intravenous infusion, on Day 1) every 3 weeks, for 2 cycles. OR Sacituzumab Tirumotecan (5 mg/kg, intravenous infusion, on Day 1) in combination with toripalimab (3 mg/kg, intravenous infusion, on Day 1) every 2 weeks, for 3 cycles. | Drug | Treatment |
| Radical Surgery for OSCCIf imaging studies following neoadjuvant therapy show a tumor response of PR or SD, or PD but the tumor is amenable to curative resection, surgery is performed. | Procedure or surgery | Treatment |
| Radiation TherapyParticipants will begin adjuvant radiation therapy 4-6 weeks after surgery. Radiation therapy will be administered using intensity-modulated radiation therapy (IMRT) at a dose of 66-70 Gy (investigators may adjust the dose appropriately based on the patient's actual condition). | Radiation | Treatment |
| CisplatinParticipants with high-risk factors, such as extracapsular lymph node invasion or inadequate surgical margins, should receive concurrent cisplatin therapy (unless the investigator determines that the patient is not suitable for cisplatin treatment). The cisplatin regimen includes a 3-week schedule (100 mg/m², at least 2 cycles) or a weekly schedule (40 mg/m², at least 5 cycles), as determined by the investigator based on the patient's individual condition. | Drug | Treatment |
Primary outcome
MPR rate
Time frame: in 4 weeks post surgery
5 secondary outcomes
Incidence and frequency of AEs and SAEs
Time frame: From first dose to 30 days after the last dose of study drug.
pCR
Time frame: in 4 weeks post surgery
ORR
Time frame: 2 years post surgery
EFS
Time frame: 2 years post surgery
OS
Time frame: 2 years post surgery
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 21 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.
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 Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab, Radical Surgery for OSCC and Radiation Therapy in people with Oral Squamous Cell Carcinoma (OSCC), run by Shanghai East 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 20 inclusion and 17 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 21 Aug 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?
Contact Ye Guo, MD (86-21-38804518, pattrickguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR rate (time frame: in 4 weeks post surgery). 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 21 Aug 2026.