NCT06218004

Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma

Prospective Clinical Study of Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hairong Liu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma .

Detailed description

This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma . After the patient signed the informed consent form, he was screened to meet the enrollment criteria and received envafolimab combined with chemotherapy according to the patient's condition. For the first imaging evaluation, if surgical treatment can be performed, neoadjuvant therapy is required to be enrolled in group A, and 3 cycles of chemotherapy combined with envafolimab are given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the treatment period, the subject should discontinue the study treatment. If the imaging evaluation cannot be surgically treated, conversion therapy can be used to enroll in group B, and 3 cycles of chemotherapy combined with envafolimab can be given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the follow-up period, the subject should discontinue the study treatment.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	Envafolimab combined with chemotherapy	envafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day.

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-23
• Last updated: 2024-01-23