Clinical IVb Stage Oral Squamous Cell Carcinomas Patients
Conditions
Keywords
Adebrelimab, PD-L1, Neoadjuvant therapy
Brief 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: • \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient's condition, with a total follow-up of two years.\].
Interventions
DRUGAdebrelimab
Adebrelimab：20mg/kg, ivdrip, D1，Q3W
Sponsors
Hospital of Stomatology, Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Oral squamous cell carcinoma patients diagnosed by histology or cytology; 2. Has not received any treatment for oral squamous cell carcinoma in the past; 3. According to the AJCC TNM staging system, stage clinical IVB; 4. ECOG score: 0-1 points; 5. Expected survival time ≥ 12 weeks; 6. 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); 7. 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; 8. Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
1. There are uncontrollable pleural effusion, pericardial effusion, or abdominal effusion that require repeated drainage; 2. Have a history of allergies to any components of adelbizumab in the past; 3. Have received any of the following treatments: 1. 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; 2. Simultaneously enroll in another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up; 3. 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; 4. 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; 5. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug; 6. Having undergone major surgery or severe trauma within 4 weeks prior to the first use of the investigational drug; 7. Patients who have previously received treatment with paclitaxel drugs; 4. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective mitigation rate（EMR） | From enrollment to the end of surgery,assessed up to 6 months | Pathological complete remission（PCR）+Major pathological relief（MPR） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | From enrollment to the first appearance of disease progression or date of death from any cause,whichever came first, assessed up to 36 months | Disease free survival |
| R0 resection rate | From enrollment to the end of surgery,whichever came first, assessed up to 6 months | :R0 is the ratio of no residue under the microscope after resection |
| ORR | From enrollment to initial efficacy evaluation,assessed up to 6 months | Objective response rate |
| mOS | From enrollment to patient death,assessed up to 50 months | Median overall survival |
Countries
China
Contacts
Primary ContactJJia Associate Professor
Outcome results
None listed