Oral Squamous Cell Carcinoma (OSCC)Phase 2NCT07137858
Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study
A Phase 2 study testing Preoperative neoadjuvant immunotherapy chemotherapy, Two courses of preoperative neoadjuvant immunotherapy chemotherapy and Three courses of preoperative neoadjuvant immunotherapy chemotherapy in people with Oral Squamous Cell Carcinoma (OSCC) and Neoadjuvant Chemoimmunotherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Preoperative neoadjuvant immunotherapy chemotherapy, Two courses of preoperative neoadjuvant immunotherapy chemotherapy and Three courses of preoperative neoadjuvant immunotherapy chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 31 Dec 2027
- 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 between 18 and 75 years old;
- According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;
- Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;
- The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;
- Blood routine: White blood cell count (WBC) ≥ 3.0×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 100×109/L; Hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatments such as blood transfusion and increase in white blood cells within 7 days);
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- Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); Albumin (ALB) ≥ 30 g/L;
- Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate (CrCl) ≥ 50 mL/min (using the Cockcroft/Gault formula); Urinary protein (UPRO) < (++), or 24-hour urine protein quantity < 1.0 gram;
- HPV status of oropharyngeal cancer was determined by p16 IHC. If more than 70% of tumor cells showed strong diffuse nuclear and cytoplasmic staining, the sample was considered p16 positive;
- Within the past 30 days, no other clinical trial projects were participated in;
- Patients who voluntarily participated in this project and signed the informed consent form.
Who cannot join
- The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.
- The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.
- Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.
- The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.
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
Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.
- Being tested
- Preoperative neoadjuvant immunotherapy chemotherapy, Two courses of preoperative neoadjuvant immunotherapy chemotherapy, Three courses of preoperative neoadjuvant immunotherapy chemotherapy
- 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.
Preoperative neoadjuvant immunotherapy chemotherapyDrug
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adalimumab 1200mg are administered intravenously. According to the allocation to the short-course group or long-course group, two or three cycles are carried out respectively, and surgery is performed 21 days after the end of the last cycle of medication. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive maintenance therapy with PD-L1 inhibitor (adalimumab) alone. Patients who require radiotherapy and chemotherapy receive maintenance therapy with the drug alone at the same time. The duration of medication for all patients is one year (calculated from the time of the first medication at the initial diagnosis to the last medication after the surgery).
Two courses of preoperative neoadjuvant immunotherapy chemotherapyDrug
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg were administered intravenously. Two treatment courses were carried out in total, and surgery was performed 21 days after the end of the second course of medication. Postoperative radiotherapy and chemotherapy were administered based on the pathological stage. Patients who did not require radiotherapy received adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who required radiotherapy and chemotherapy received monotherapy maintenance during the same period. The duration of medication for all patients was one year (from the first medication time at the initial diagnosis to the last medication time after surgery).
Three courses of preoperative neoadjuvant immunotherapy chemotherapyDrug
Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg are administered intravenously. This treatment is carried out for a total of three cycles, and surgery is performed 21 days after the end of the third cycle. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who require radiotherapy and chemotherapy receive monotherapy maintenance simultaneously. The duration of medication for all patients is one year (from the first administration after diagnosis to the last administration after surgery).
| Study group | Role | What they receive |
|---|---|---|
| Short-distance group | Experimental | Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg were administered intravenously. Two treatment courses were carried out in total, and surgery was performed 21 days after the end of the second course of medication. Postoperative radiotherapy and chemotherapy were administered based on the pathological stage. Patients who did not require radiotherapy received adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who required radiotherapy and chemotherapy received monotherapy maintenance during the same period. The duration of medication for all patients was one year (from the first medication time at the initial diagnosis to the last medication time after surgery). Receives: Drug: Preoperative neoadjuvant immunotherapy chemotherapy; Drug: Two courses of preoperative neoadjuvant immunotherapy chemotherapy |
| Long-distance group | Active comparator | Each treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg are administered intravenously. This treatment is carried out for a total of three cycles, and surgery is performed 21 days after the end of the third cycle. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who require radiotherapy and chemotherapy receive monotherapy maintenance simultaneously. The duration of medication for all patients is one year (from the first administration after diagnosis to the last administration after surgery). Receives: Drug: Preoperative neoadjuvant immunotherapy chemotherapy; Drug: Three courses of preoperative neoadjuvant immunotherapy chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pathological complete response rate
There were no residual tumor cells in the pathological sections of the surgically resected primary lesion and lymph node specimens. The main judgment method is that the postoperative specimen is sent to the pathology department for fixation, sectioning, and observation. Two pathologists read the images to determine whether the tumor was residual. If there was any disagreement between them, the third senior pathologist would discuss and decide.
Measured: All patients were treated within 7 working days after surgery
Secondary outcomes (4)
Major pathological response rate
Proportion of patients with 10% or less viable tumor cells in the primary lesion specimen.
Measured: All patients were treated within 7 working days after surgery
Objective tumor response rate
Measured: All patients were treated 21 days after the last dose of preoperative neoadjuvant immunochemotherapy
Event-free survival at 2 years
Measured: Within 2 years after completion of all treatments
The overall survival rates for 2 years and 5 years
Measured: Within the next 2 years and 5 years after all treatments are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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 Sun Yat-Sen Memorial Hospital of 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137858
- Sponsor's protocol ID
- SYSKY-2025-487-02
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT07137858
- Acronym / sponsor ID
- SYSKY-2025-487-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Aug 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.
Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-distance group | Experimental | Drug: Preoperative neoadjuvant immunotherapy chemotherapy, Drug: Two courses of preoperative neoadjuvant immunotherapy chemotherapyEach treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg were administered intravenously. Two treatment courses were carried out in total, and surgery was performed 21 days after the end of the second course of medication. Postoperative radiotherapy and chemotherapy were administered based on the pathological stage. Patients who did not require radiotherapy received adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who required radiotherapy and chemotherapy received monotherapy maintenance during the same period. The duration of medication for all patients was one year (from the first medication time at the initial diagnosis to the last medication time after surgery). |
| Long-distance group | Active comparator | Drug: Preoperative neoadjuvant immunotherapy chemotherapy, Drug: Three courses of preoperative neoadjuvant immunotherapy chemotherapyEach treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg are administered intravenously. This treatment is carried out for a total of three cycles, and surgery is performed 21 days after the end of the third cycle. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who require radiotherapy and chemotherapy receive monotherapy maintenance simultaneously. The duration of medication for all patients is one year (from the first administration after diagnosis to the last administration after surgery). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 75 years old;
- According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;
- Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;
- The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;
Key exclusion criteria (4 listed)
- The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.
- The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.
- Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.
- The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.
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 |
|---|---|---|
| Preoperative neoadjuvant immunotherapy chemotherapyEach treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adalimumab 1200mg are administered intravenously. According to the allocation to the short-course group or long-course group, two or three cycles are carried out respectively, and surgery is performed 21 days after the end of the last cycle of medication. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive maintenance therapy with PD-L1 inhibitor (adalimumab) alone. Patients who require radiotherapy and chemotherapy receive maintenance therapy with the drug alone at the same time. The duration of medication for all patients is one year (calculated from the time of the first medication at the initial diagnosis to the last medication after the surgery). | Drug | Long-distance group, Short-distance group |
| Two courses of preoperative neoadjuvant immunotherapy chemotherapyEach treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg were administered intravenously. Two treatment courses were carried out in total, and surgery was performed 21 days after the end of the second course of medication. Postoperative radiotherapy and chemotherapy were administered based on the pathological stage. Patients who did not require radiotherapy received adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who required radiotherapy and chemotherapy received monotherapy maintenance during the same period. The duration of medication for all patients was one year (from the first medication time at the initial diagnosis to the last medication time after surgery). | Drug | Short-distance group |
| Three courses of preoperative neoadjuvant immunotherapy chemotherapyEach treatment course lasts for three weeks. On the first day of each three-week period, albumin-bound paclitaxel 260mg/m2, carboplatin AUC=5 and adebrelimab 1200mg are administered intravenously. This treatment is carried out for a total of three cycles, and surgery is performed 21 days after the end of the third cycle. Post-surgery, radiotherapy and chemotherapy are administered based on the pathological stage. Patients who do not require radiotherapy receive adebrelimab (PD-L1 inhibitor) monotherapy maintenance. Patients who require radiotherapy and chemotherapy receive monotherapy maintenance simultaneously. The duration of medication for all patients is one year (from the first administration after diagnosis to the last administration after surgery). | Drug | Long-distance group |
Primary outcome
Postoperative pathological complete response rate
Time frame: All patients were treated within 7 working days after surgery
There were no residual tumor cells in the pathological sections of the surgically resected primary lesion and lymph node specimens. The main judgment method is that the postoperative specimen is sent to the pathology department for fixation, sectioning, and observation. Two pathologists read the images to determine whether the tumor was residual. If there was any disagreement between them, the third senior pathologist would discuss and decide.
4 secondary outcomes
Major pathological response rate
Time frame: All patients were treated within 7 working days after surgery
Objective tumor response rate
Time frame: All patients were treated 21 days after the last dose of preoperative neoadjuvant immunochemotherapy
Event-free survival at 2 years
Time frame: Within 2 years after completion of all treatments
The overall survival rates for 2 years and 5 years
Time frame: Within the next 2 years and 5 years after all treatments are completed
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 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative neoadjuvant immunotherapy chemotherapy, Two courses of preoperative neoadjuvant immunotherapy chemotherapy and Three courses of preoperative neoadjuvant immunotherapy chemotherapy in people with Oral Squamous Cell Carcinoma (OSCC) and Neoadjuvant Chemoimmunotherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 4 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 22 Aug 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 Yilin He (+86 13680281880, heylin5@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pathological complete response rate (time frame: All patients were treated within 7 working days after 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 22 Aug 2025.