Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck

NCT06016413 | Not Yet Recruiting Phase 2

• 1 other identifier: SYSKY-2023-616-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; immunity therapy; PD-L1

Outcome Measures

Primary Outcomes (1)

• Postoperative pathological complete response rate

  The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide

  one week after operative

Secondary Outcomes (2)

• Major pathological response rate

  one week after operative

• Two years overall Survival

  Two years after investigator enrollment

Study Arms (1)

intervention group

EXPERIMENTAL

All patients received nab-paclitaxel 260 mg/m2, carboplatin AUC=5 and adelbelimumab 1200 mg intravenously on day 1 of each 3-week cycle for 3 cycles. All patients were given conventional drugs to prevent vomiting in each cycle, and intravenous dexamethasone was given to prevent allergy before each dose

Drug: Nab paclitaxel; Drug: Carboplatin; Drug: adelbelimumab

Interventions

Nab paclitaxel DRUG

All patients received nab-paclitaxel 260 mg/m2 intravenously on day 1 of each 3-week cycle for 3 cycles.

intervention group

Carboplatin DRUG

All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.

intervention group

adelbelimumab DRUG

All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.

intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years old
• According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors
• Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
• According to RECIST 1.1, there is at least one measurable tumor lesion
• The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
• Blood routine: white blood cell count (WBC) ≥ 3.0×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatment such as blood transfusion and leukocytosis within 7 days).
• Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients without liver metastasis ≤ 2.5 times the upper limit of the reference value (ULN); albumin (ALB) ≥ 30 g /L.
• Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50mL/min (using the Cockcroft/Galter formula); urine protein (UPRO) \< (++), or 24 Hourly urine protein \< 1.0 g.
• Determination of HPV status in oropharyngeal cancers using p16 IHC. A sample was considered p16 positive if \>70% of tumor cells exhibited intense diffuse nuclear and cytoplasmic staining
• Have not participated in other clinical trial projects in the past 30 days;
• Patients who voluntarily participate in the project and sign the informed consent.

You may not qualify if:

• The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
• The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
• The entire clinical research process cannot be completed due to personal, social and economic reasons
• Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

Related Publications (14)

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MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Taxes; Carboplatin

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)

Economics; Health Care Economics and Organizations; Coordination Complexes; Organic Chemicals

Central Study Contacts

Zhiquan Huang

CONTACT

13826142898; hzhquan@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

CN (1)