Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07055841 | Recruiting Phase 2

• 1 other identifier: 23-OBU-SD-HNC-II-003
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

PD-L1; Local late stage

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate (ORR)

  From enrollment to first efficacy evaluation (around 6-8 weeks)

Secondary Outcomes (4)

• pCR

  Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery

• R0 resection rate

  Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery

• EFS

  The time from enrollment to the first occurrence of endpoint events such as disease progression and death(maximum follow-up time of 2 years)

• Adverse event incidence rate

  Follow up from enrollment until 90 days after the last treatment

Study Arms (1)

Group 1

EXPERIMENTAL

TP regimen Adbelimab Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.

Drug: Adebrelimab; Drug: TP regimen; Procedure: Surgery or radiotherapy

Interventions

Adebrelimab DRUG

1200mg, intravenous infusion, D1， Every three weeks, there are two cycles in total.

Group 1

TP regimen DRUG

TP regimen: Docetaxel 75 mg/m2, intravenous infusion, D1， Cisplatin 75 mg/m2, intravenous infusion, D1， Every three weeks, there are two cycles in total.

Group 1

Surgery or radiotherapy PROCEDURE

Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.

Group 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with head and neck squamous cell carcinoma diagnosed by histology or cytology;
• \. Have not received systematic treatment for head and neck squamous cell carcinoma in the past;
• \. According to the AJCC TNM staging system, it is divided into stages III-IVB;
• \. ECOG score: 0-1 point;
• \. Expected survival period ≥ 12 weeks;
• \. The main organ functions well 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 laboratory values in the research center), 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 ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
• \. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period, at least 6 months after the last use of adebelimab, and at least 6 months after the last use of chemotherapy;
• \. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• \. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
• \. Have a history of allergies to any components of Adabelimab in the past;
• \. Have received any of the following treatments:
• Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
• Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
• Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
• Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone 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, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
• Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
• Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
• Patients who have received previous treatment with paclitaxel drugs;
• \. Active autoimmune diseases, history of 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 childhood asthma/allergies with vitiligo or those who have already recovered, patients who 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 subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class 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;
• Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0\>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; 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 administration Or intravenous use of antibiotics for treatment, except for prophylactic use of antibiotics;
• \. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);

Sponsors & Collaborators

• Xiuping Ding: lead

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

TP protocol; Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• wanjun chen, physician

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuping Ding, Dr.

CONTACT

+86 18654539599; drdxp85@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 9, 2025
• Study Start: April 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)