Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2026

Conditions
Locally Advanced Hypopharyngeal Carcinoma
Interventions
DRUG

three cycles (toripalimab + cetuximab + platinum)

Cetuximab 250 mg/m2 i.v. qw (first loading dose 400 mg/m2) for nine doses; Toripalimab 240 mg/m2 i.v. d1, q21d, three cycles; Cisplatin 25 mg/m2 i.v. d1-3, q21d, three cycles or Carboplatin AUC 5 i.v. d1, q21d, three cycles (patients with cisplatin contraindications or renal impairment after cisplatin use).

PROCEDURE

Radical surgery

The attending physician should select the appropriate surgical treatment and try to perform radical laryngeal preservation surgery for patients with tumor retraction after induction therapy. Patients who cannot preserve laryngeal function due to tumor load need to undergo total laryngeal resection. According to the scope of pharyngectomy, the surgical treatments include partial laryngopharyngectomy, total laryngectomy and partial pharyngectomy, total laryngopharyngectomy, and total pharyngo-laryngo-esophagectomy. Cervical lymph node dissection was performed when necessary.

RADIATION

Radiotherapy or chemoradiotherapy

"1. Using intensity-modulated radiotherapy (IMRT) technology, the dose of radiotherapy is determined according to whether there are adverse prognostic factors in the postoperative pathology, including positive margins, extracapsular invasion of lymph nodes, primary pT3 or T4, N2 lymph node lesions, peripheral nerve invasion, vascular/lymphatic infiltration.~ Primary site: residual GTV or tumor bed dose 60-70Gy: 1.8-2.12 Gy / fraction. Cervical lymph nodes or lymphatic drainage area: 56-70 Gy: 1.7-2.12 Gy / fraction.~2. Postoperative adjuvant concurrent chemotherapy regimen:~Cisplatin 25mg/m2 i.v. d1-3, d22-24 or Carboplatin AUC 5 i.v. d1, d22 (if cisplatin contraindications)."

Trial Locations (1)

200031

RECRUITING

Eye & ENT Hospital of Fudan University, Shanghai

All Listed Sponsors
lead

Eye & ENT Hospital of Fudan University

OTHER