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Clinical IVb Stage Oral Squamous Cell Carcinomas PatientsPhase 2NCT06277791

The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma

A Phase 2 study testing Adebrelimab in people with Clinical IVb Stage Oral Squamous Cell Carcinomas Patients, run by Hospital of Stomatology, Wuhan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this [type of study:clinical trial] is to [learn about] in [Clinical IVB stage oral squamous cell carcinoma patients]. The main question it aims to answer are: [Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adebrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
19 Aug 2023to 31 Jul 2026
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

  • Oral squamous cell carcinoma patients diagnosed by histology or cytology;
  • Has not received any treatment for oral squamous cell carcinoma in the past;
  • According to the AJCC TNM staging system, stage clinical IVB;
  • ECOG score: 0-1 points;
  • Expected survival time ≥ 12 weeks;
  • The main organ function is good, and the laboratory test data meets the following standards: (1) Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal values in the research center laboratory), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times the ULN. If the patient has liver metastasis, this standard is ≤ 5 times the ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to Cockcroft Gault formula);
  • Female participants with fertility, as well as male participants with partners who are fertile women, are required to use a medically recognized contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period, and at least 6 months after the last use of adelbizumab and at least 6 months after the last use of chemotherapy;
  • Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.

Who cannot join

  • There are uncontrollable pleural effusion, pericardial effusion, or abdominal effusion that require repeated drainage;
  • Have a history of allergies to any components of adelbizumab in the past;
  • Have received any of the following treatments:
  • Received any other investigational medication within 4 weeks prior to the first use of the investigational medication, or had a half-life of no more than 5 weeks from the last investigational medication;
  • Simultaneously enroll in another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up;
  • Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
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  • Subjects who need to receive corticosteroids (\>10mg prednisone equivalent dose per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortex hormone replacement with a dose greater than 10mg/day of prednisone efficacy dose;
  • Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug;
  • Having undergone major surgery or severe trauma within 4 weeks prior to the first use of the investigational drug;
  • Patients who have previously received treatment with paclitaxel drugs;
  • The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 level 1 (excluding hair loss) or the level specified by the inclusion/exclusion criteria;
  • A history of active autoimmune diseases and autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding patients with vitiligo or childhood asthma/allergies who have already recovered and do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
  • Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have 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);
  • The subjects have uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
  • Serious infections (CTCAE 5.0\>Level 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications that require hospitalization treatment; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics;
  • History of interstitial lung disease (excluding radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
  • Patients who have been diagnosed with active pulmonary tuberculosis infection through medical history or CT examination, or have a history of active pulmonary tuberculosis infection within one year before enrollment, or have a history of active pulmonary tuberculosis infection more than one year before but have not received formal treatment;
  • Diagnosed with any other malignant tumor within the 5 years prior to the first use of the investigational drug, excluding malignant tumors with low risk of metastasis and mortality (5-year survival rate\>90%), such as basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been adequately treated;
  • Pregnant or lactating women;
  • According to the researcher\'s judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormalities in laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JJia Associate Professor contact

+8613277924848

junjia@whu.edu.cn

China1 site, 1 recruiting

  • School of Stomatology Wuhan University

    Hubei, Wuhan, 430079

    JJia Associate Professor, +8613277924848, junjia@whu.edu.cn

    zili Yu

    Recruiting

Other trials in China

About this study

Official title: A Single Arm, Exploratory Clinical Study of the Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma in Clinical Practice

The goal of this [type of study:clinical trial] is to [learn about] in [Clinical IVB stage oral squamous cell carcinoma patients]. The main question it aims to answer are:

  • [Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients] Participants will [Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.].
Being tested
Adebrelimab
Keywords
Adebrelimab, PD-L1, Neoadjuvant therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    Adebrelimab：20mg/kg, ivdrip, D1，Q3W

Study groups in NCT06277791
Study groupRoleWhat they receive
Treatment groupExperimentalTP: docetaxel 75 mg/m2, cisplatin 75 mg/m2 Adebrelimab: 20mg/kg, intravenous infusion, D1 Every three weeks, a total of two cycles. Surgery will be performed 1-3 weeks after the completion of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, and a total of two years of follow-up were conducted.
Receives: Drug: Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effective mitigation rate（EMR）

    Pathological complete remission（PCR）+Major pathological relief（MPR）

    Measured: From enrollment to the end of surgery,assessed up to 6 months

Secondary outcomes (4)

  1. DFS

    Disease free survival

    Measured: From enrollment to the first appearance of disease progression or date of death from any cause,whichever came first, assessed up to 36 months

  2. R0 resection rate

    :R0 is the ratio of no residue under the microscope after resection

    Measured: From enrollment to the end of surgery,whichever came first, assessed up to 6 months

  3. ORR

    Objective response rate

    Measured: From enrollment to initial efficacy evaluation,assessed up to 6 months

  4. mOS

    Median overall survival

    Measured: From enrollment to patient death,assessed up to 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start19 Aug 2023
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277791
Sponsor's protocol ID
HStomatologyWuhan1
Status last verified
May 2025
First submitted
30 Jan 2024
Last updated
29 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab in people with Clinical IVb Stage Oral Squamous Cell Carcinomas Patients, run by Hospital of Stomatology, Wuhan 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 8 inclusion and 20 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 29 May 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?

Effective mitigation rate（EMR） (time frame: From enrollment to the end of surgery,assessed up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277791.

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 29 May 2025.

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