Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC

NCT05516589 | Completed Phase 2

• 1 other identifier: ChiECRCT20210621
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficiency and safety of TP chemotherapy, tislelizumab, combined with afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; Neoadjuvant therapy; Immunotherapy; EGFR-TKI; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Pathologic complete response was defined as the absence of viable tumor cells.

  Time of surgery

Secondary Outcomes (5)

• Major Pathologic Response

  Time of surgery

• Objective Response Rate

  Up to 8 weeks

• Adverse Events

  Up to 12 weeks

• Disease-free Survival

  1 year

• Overall Survival

  1 year

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Participants will receive * TP chemotherapy every 3 weeks x 2 cycles (Nab-paclitaxel 260mg/m\^2 IV on day1, Cisplatin 75mg/m\^2 IV on day 1); * Tislelizumab 200mg IV every 3 weeks x 2 cycles; * Afatinib 30mg PO everyday x 6 weeks.

Drug: Nab-paclitaxel; Drug: Cisplatin; Biological: Tislelizumab; Drug: Afatinib

Interventions

Nab-paclitaxel DRUG

260mg/m\^2 IV Q3W

Also known as: Albumin-bound paclitaxel, Abraxane

Treatment Cohort

Cisplatin DRUG

75mg/m\^2 IV Q3W

Also known as: CDDP

Treatment Cohort

Tislelizumab BIOLOGICAL

200mg IV Q3W

Also known as: BGB-A317

Treatment Cohort

Afatinib DRUG

30mg PO QD

Treatment Cohort

Eligibility Criteria

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

You may qualify if:

• Age 18 years or above.
• Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:
• were newly diagnosed and without distant metastasis;
• were deemed surgically resectable evaluated by a head and neck surgeon;
• were willing to undergo surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate organ and bone marrow function:
• absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;
• ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;
• albumin≥ 2.8 g/dL；
• creatinine clearance ≥ 60 ml/min；
• INR≤ 1.5；APTT≤ 1.5×ULN；
• Written informed consent.

You may not qualify if:

• History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
• Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
• Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
• Any of prior therapy with:
• anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs；
• antitumor vaccine;
• any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period;
• major surgery or serious trauma within 4 weeks before the first dose;
• With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
• With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
• With hyperthyroidism, or organic thyroid disease.
• With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
• With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
• History of a clear neurological or psychiatric disorder.
• History of drug abuse or alcohol abuse.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; tislelizumab; Afatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Amides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xingchen Peng, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 25, 2022
• Study Start: September 12, 2022
• Primary Completion: October 29, 2023
• Study Completion: December 31, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)