Early-Stage Oral Squamous Cell CarcinomaPhase 2NCT07007364
Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
A Phase 2 study testing Adebrelimab Combined With Albumin Paclitaxel in people with Early-Stage Oral Squamous Cell Carcinoma, run by Jun Jia at 1 site in China.
Trial summary
This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early-Stage Oral Squamous Cell Carcinoma
- What is being tested?
- Adebrelimab Combined With Albumin Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2025to 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70, gender not limited;
- Confirmed by pathological examination as oral squamous cell carcinoma (anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard palate, posterior molar area);
- Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) according to the 8th edition of the clinical staging system of the American Joint Committee on Cancer;
- ECOG 0-1 point;
- Vital organs function normally and can tolerate the prescribed treatment plan:
- There was no obvious abnormality in bone marrow hematopoietic function before treatment: white blood cell count ≥3.5×109/L, neutrophil count ≥2.0×109/L; Hemoglobin ≥100g/L Platelet count ≥100×109/L;
Show all 10Show fewer
- No obvious abnormalities were observed in liver and kidney functions before treatment: Total bilirubin ≤1.5 times the upper limit of normal; Aspartate aminotransferase and/or alanine aminotransferase ≤2.5 times the normal upper limit; Alkaline phosphatase ≤2.5 times the normal upper limit; Creatinine clearance rate ≥60 mL/min;
- The examination results of thyroid function, coagulation function, pituitary function, inflammatory infection indicators, myocardial enzymes, electrocardiogram and echocardiography are normal;
- Women of childbearing age (18-49 years old) have negative serum or urine HCG tests within 7 days before treatment and agree to use medically approved contraceptive measures during the treatment period and within 120 days after the end of treatment;
- Sign the informed consent form, voluntarily participate in the clinical trial research project, and be willing and able to comply with the follow-up, treatment, laboratory testing and other research requirements stipulated in the research schedule.
Who cannot join
- 1. There is uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage; 2. There is a history of allergy to adbelimab in the past; 3. Has received any of the following treatments:
- Having received any other investigational drugs within 4 weeks before the first use of the investigational drug or no more than 5 half-lives from the last investigational drug use;
- Enroll in another clinical study simultaneously, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study;
- Have received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 2 weeks before the first use of the study drug;
- Subjects who need to be given corticosteroids (an equivalent dose of > 10 mg prednisone per day) within 2 weeks before the first use of the study drug. Hormones are allowed for routine chemotherapy pretreatment without the need to adjust the dosage. In other special circumstances, communication with the researcher is required. In the absence of active autoimmune diseases, inhaled or topical use of steroids and adrenal cortical hormones with a dose of ≤10 mg/ day of prednisone as an therapeutic dose is permitted.
- Those who have received anti-tumor vaccines or those who have received live vaccines within 4 weeks before the first administration of the study drug;
Show all 9Show fewer
- Underwent major surgery or suffered severe trauma within 4 weeks before the first use of the study drug;
- Patients who have previously received treatment with taxanes; 4. The toxicity of previous anti-tumor treatments has not recovered to ≤CTCAE 5.0 grade 1 (except for alopecia) or the level specified in the inclusion/exclusion criteria; 5. Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, liver inflammation, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding patients with vitiligo or childhood asthma/allergies that have been cured and do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes using a stable dose of insulin; 6. Have a history of immunodeficiency, including a positive HIV test, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies /mL); 7. The subjects have poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: such as: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris (3) Had a myocardial infarction within one year; (4) Supraventricular or ventricular arrhythmias of clinical significance that have not undergone clinical intervention or remain poorly controlled after clinical intervention; 8. Severe infections (CTCAE 5.0 > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, and complications of infection, etc. Baseline chest imaging examinations indicated the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding the cases of preventive antibiotic use.
- 9. Have a history of interstitial lung disease (except for radiation pneumonitis and non-infectious pneumonia that have not received hormone therapy); 10. Patients who were found to have active pulmonary tuberculosis infection through medical history or CT examination, or those who had a history of active pulmonary tuberculosis infection within one year before enrollment, or those who had a history of active pulmonary tuberculosis infection more than one year ago but have not received formal treatment; 11. Any other malignant tumor was diagnosed within 5 years prior to the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 12. Pregnant or lactating women; 13. As judged by the researcher, the subjects have other factors that may cause them to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) requiring combined treatment, having severely abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data
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, 1 recruiting
- Recruiting
Hospital of Stomatology, Wuhan University
Wuhan, Hubei
About this study
This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Eligible patients received neoadjuvant low-dose radiotherapy combined with adibelizumab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy. The primary endpoints were the rate of pathological response and the rate of exemption from cervical lymph node dissection. The secondary endpoints included progression-free survival, local control rate, distant metastasis-free rate, overall survival, safety and quality of life of patients, as well as the exploration of biomarkers
- Conditions
- Early-Stage Oral Squamous Cell Carcinoma
- Being tested
- Adebrelimab Combined With Albumin Paclitaxel
- 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.
Adebrelimab Combined With Albumin PaclitaxelDrug
Eligible patients received neoadjuvant low-dose radiotherapy combined with Adebrelimab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant low-dose radiotherapy combined with adebrelimab and monotherapy with albumin paclitaxel | Experimental | Eligible patients received neoadjuvant low-dose radiotherapy combined with Adebrelimab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy Receives: Drug: Adebrelimab Combined With Albumin Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
The percentage of viable tumor cells remaining in the tumor bed after neoadjuvant therapy is ≤10%, regardless of whether viable tumor cells remain in the lymph nodes
Measured: From enrollment to the end of surgery,assessed up to 6 months
The rate of exemption from cervical lymph node dissection surgery
During the operation, multiple biopsies were performed on the primary lesion. If no tumor cells were found, cervical lymph node dissection was waived
Measured: From enrollment to the end of surgery,assessed up to 6 months
Secondary outcomes (2)
PFS
The calculation starts from the day of enrollment until treatment failure, death due to any cause, or the last follow-up occurs, with the first occurrence as the endpoint
Measured: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 months
LRFS
The calculation starts from the day of enrollment until local and/or regional recurrence occurs or at the last follow-up
Measured: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start19 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Oral Squamous Cell CarcinomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Jia, Hospital of Stomatology, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007364
- Sponsor's protocol ID
- HStomatologyWuhan2
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07007364
- Acronym / sponsor ID
- HStomatologyWuhan2
- Conditions
- Early-Stage Oral Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jun JiaUniversity, hospital or other
- Study start
- 19 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 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.
This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Eligible patients received neoadjuvant low-dose radiotherapy combined with adibelizumab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy. The primary endpoints were the rate of pathological response and the rate of exemption from cervical lymph node dissection. The secondary endpoints included progression-free survival, local control rate, distant metastasis-free rate, overall survival, safety and quality of life of patients, as well as the exploration of biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant low-dose radiotherapy combined with adebrelimab and monotherapy with albumin paclitaxel | Experimental | Drug: Adebrelimab Combined With Albumin PaclitaxelEligible patients received neoadjuvant low-dose radiotherapy combined with Adebrelimab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 to 70, gender not limited;
- Confirmed by pathological examination as oral squamous cell carcinoma (anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard palate, posterior molar area);
- Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) according to the 8th edition of the clinical staging system of the American Joint Committee on Cancer;
- ECOG 0-1 point;
- Vital organs function normally and can tolerate the prescribed treatment plan:
Key exclusion criteria (9 listed)
- 1. There is uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage; 2. There is a history of allergy to adbelimab in the past; 3. Has received any of the following treatments:
- 9. Have a history of interstitial lung disease (except for radiation pneumonitis and non-infectious pneumonia that have not received hormone therapy); 10. Patients who were found to have active pulmonary tuberculosis infection through medical history or CT examination, or those who had a history of active pulmonary tuberculosis infection within one year before enrollment, or those who had a history of active pulmonary tuberculosis infection more than one year ago but have not received formal treatment; 11. Any other malignant tumor was diagnosed within 5 years prior to the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 12. Pregnant or lactating women; 13. As judged by the researcher, the subjects have other factors that may cause them to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) requiring combined treatment, having severely abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data
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 |
|---|---|---|
| Adebrelimab Combined With Albumin PaclitaxelEligible patients received neoadjuvant low-dose radiotherapy combined with Adebrelimab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy | Drug | Neoadjuvant low-dose radiotherapy combined with adebrelimab and monotherapy with albumin paclitaxel |
Primary outcome
MPR
Time frame: From enrollment to the end of surgery,assessed up to 6 months
The percentage of viable tumor cells remaining in the tumor bed after neoadjuvant therapy is ≤10%, regardless of whether viable tumor cells remain in the lymph nodes
The rate of exemption from cervical lymph node dissection surgery
Time frame: From enrollment to the end of surgery,assessed up to 6 months
During the operation, multiple biopsies were performed on the primary lesion. If no tumor cells were found, cervical lymph node dissection was waived
2 secondary outcomes
PFS
Time frame: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 months
LRFS
Time frame: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 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 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Early-Stage Oral Squamous Cell Carcinoma
Recruiting
Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC
Oral Cancer, Lymph Node Metastasis
Not yet recruitingPhase 3
Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma
Oral Squamous Cell Carcinoma (OSCC), Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2/3
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma
Recruiting
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Carcinoma, Squamous Cell
Recruiting
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
Oral Tongue 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.
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 Adebrelimab Combined With Albumin Paclitaxel in people with Early-Stage Oral Squamous Cell Carcinoma, run by Jun Jia 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Jun 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 JJia Associate Professor (+8613277924848, junjia@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: From enrollment to the end of surgery,assessed up to 6 months). The study lists 2 primary outcomes in all. 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 27 Jun 2025.