Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial (neoCHANCE-2 Trial)

Status: Completed
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital, Sichuan University
Chengdu
Time Frame
Start Date: 2022-09-12
Completion Date: 2024-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Treatment Cohort
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.
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov

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