Early-Stage Oral Squamous Cell Carcinoma
Conditions
Brief 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. 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
Interventions
DRUGAdebrelimab Combined With Albumin Paclitaxel
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
Sponsors
Jun Jia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 to 70, gender not limited; 2. 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); 3. 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; 4. ECOG 0-1 point; 5. Vital organs function normally and can tolerate the prescribed treatment plan: 1. 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; 2. 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; 3. The examination results of thyroid function, coagulation function, pituitary function, inflammatory infection indicators, myocardial enzymes, electrocardiogram and echocardiography are normal; 6. 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; 7. 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.
Exclusion criteria
* 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: 1. 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; 2. Enroll in another clinical study simultaneously, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study; 3. 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; 4. 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. 5. 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; 6. Underwent major surgery or suffered severe trauma within 4 weeks before the first use of the study drug; 7. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MPR | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 months | 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 |
| LRFS | From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 36 months | The calculation starts from the day of enrollment until local and/or regional recurrence occurs or at the last follow-up |
Countries
China
Contacts
Primary ContactJJia Associate Professor
Outcome results
None listed