PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma

NCT06125223 | Not Yet Recruiting

• 1 other identifier: KY20232325
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy. Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoadjuvant Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy.

  pCR means that there are no residual living tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.

  About 50 days after the start of neoadjuvant immunotherapy.

Secondary Outcomes (5)

• ORR(objective response rate)

  At least 1 year.

• R0 resection rate

  At least 1 year.

• MPR（major pathological response）

  At least 1 year.

• Overall survival rate

  At least 1 year.

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  At least 1 year.

Other Outcomes (1)

• clearance of peripheral blood ctDNA

  At least 1 year.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A otolaryngology patient at Xijing Hospital.

You may qualify if:

• age 18-80 years old, including 18 years old and 80 years old;
• MRI diagnosis of resectable stage III-IVA oropharynx, larynx and hypopharynx squamous-cell carcinoma confirmed by histopathology or cytology;
• ECOG PS score 0-1;
• the expression of PD-L1 was detected by immunohistochemistry (TPS and CPS score)
• having at least one measurable lesion according to RECIST version 1.1;
• expected survival time ≥6 months;
• The neutrophil count was ≥1.5 × 10\^9/L, the platelet count was ≥100 × 10\^9/L, the hemoglobin count was ≥90 g/L
• renal function was normal: serum creatinine ≤1.5×ULN;
• the liver function was basically normal: serum total bilirubin ≤1.5 × ULN, serum aspartate transaminase (AST)≤2.5×ULN, serum Alanine transaminase (ALT)≤2.5 ×ULN;
• female patients had to be negative for a urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) ;
• Sign the written informed consent.

You may not qualify if:

• patients were treated with anti-tumor drugs including but not limited to PD-1 inhibitor, CTLA-4 antibody, EGFR monoclonal antibody, EGFR-tki, and anti-angiogenesis drugs;
• History of autoimmune diseases including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, Rheumatoid Arthritis, inflammatory bowel disease, Antiphospholipid syndrome vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
• participated in other intervention clinical trials within 30 days before screening;
• history of other malignancies (except cured skin basal-cell carcinoma) ;
• the presence of serious and poorly controlled co-morbidities (e.g. heart failure, diabetes, hypertension, liver failure, kidney failure, thyroid disease, mental illness, etc.) ;
• Known to be infected with HIV or active hepatitis or tuberculosis;
• major surgery or planned surgery within 30 days before the first dose of the trial drug;
• Persons who are allergic to the use of drugs or their components in the programme;
• pregnancy (confirmed by blood or urine HCG testing) or lactation in women, or in subjects of reproductive age who were unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
• it is not suitable for the researcher to participate in this study;
• Unwilling to participate in the study or unable to sign the informed consent.

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (12)

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• Ferris RL, Spanos WC, Leidner R, Goncalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6):e002568. doi: 10.1136/jitc-2021-002568.

  PMID: 34083421 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 9, 2023

Record last verified: 2023-11