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

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.].

Study Overview

• Status: Recruiting
• Conditions: Clinical IVb Stage Oral Squamous Cell Carcinomas Patients
• Intervention / Treatment: Drug: Adebrelimab

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JJia Associate Professor; Phone Number: +8613277924848; Email: junjia@whu.edu.cn

Study Locations

• China
  • Wuhan
    • Hubei, Wuhan, China, 430079
      • Recruiting
      • School of Stomatology Wuhan University
      • Contact: JJia Associate Professor; Phone Number: +8613277924848; Email: junjia@whu.edu.cn
      • Principal Investigator: zili Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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/exclusion criteria;
5. 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;
6. 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);
7. 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;
8. 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;
9. History of interstitial lung disease (excluding radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
10. 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;
11. 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;
12. Pregnant or lactating women;
13. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment group; TP: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective mitigation rate（EMR）	Pathological complete remission（PCR）+Major pathological relief（MPR）	From enrollment to the end of surgery,assessed up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Disease free survival	From enrollment to the first appearance of disease progression or date of death from any cause,whichever came first, assessed up to 36 months
R0 resection rate	:R0 is the ratio of no residue under the microscope after resection	From enrollment to the end of surgery,whichever came first, assessed up to 6 months
ORR	Objective response rate	From enrollment to initial efficacy evaluation,assessed up to 6 months
mOS	Median overall survival	From enrollment to patient death,assessed up to 50 months

Collaborators and Investigators

• Sponsor: Hospital of Stomatology, Wuhan University
• Investigators: Study Director: J Jia, Associate Professor, School of Stomatology Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PD-L1; Neoadjuvant therapy; Adebrelimab
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: HStomatologyWuhan1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No