461TiP - TRENT-001: A phase II study of PD-1 inhibitors plus chemotherapy as induction therapy in patients with poorly differentiated locally advanced head and neck squamous cell carcinoma

Background

Poorly differentiated squamous cell carcinoma has a worse prognosis, and independent prospective clinical research data are lacking. Extensive research conducted on the combination of PD-1 inhibitors with chemotherapy induction therapy in the treatment of locally advanced head and neck squamous cell carcinoma (LA HNSCC) has consistently demonstrated an objective response rate (ORR) exceeding 80% and a pathological complete response (pCR) rate of over 30%. This new treatment model may bring potential survival benefits. This single-center, prospective, two-cohort study will evaluate efficacy and safety of PD-1 inhibitors plus chemotherapy as induction therapy in patients with poorly differentiated LA HNSCC.

Trial design

Patients with untreated LA HNSCC who met the inclusion criteria will be divided into two treatment arms. Arm 1 will be given 2 cycles of pembrolizumab (200mg, Q3W) + paclitaxel-albumin (260mg/m², Q3W) + cisplatin (75mg/m², Q3W). If the imaging assessment is CR /PR, surgical treatment will be performed (the postoperative treatment mode is consistent with Arm2). If SD/PD, CCRT (RT: 66-70 Gy) ± pembrolizumab maintenance therapy will be performed (Consider one more cycle of induction therapy before RT). Arm2 will undergo 2 cycles induction therapy. If CR, RT (66-70Gy) ± pembrolizumab maintenance therapy will be given. If it is not CR, surgical treatment will be given. According to the pathological results of the primary lesion, patients with pCR will receive low-dose RT (40-50Gy) + pemrbolizumab maintenance therapy. If it is not pCR, CCRT (positive margin or extracapsular invasion) / RT (66-70 Gy) + pemrbolizumab maintenance therapy will be given. Eligibility criteria will include age ≥18 years; poorly differentiated HNSCC; untreated with systemic treatment; Arm 1 should meet the staging criteria of T3NxM0 or T4aNxM0 (AJCC 8th edition); Arm 2 should meet the staging criteria of T4NxM0; ECOG performance status 0-1. Primary end points is ORR. Secondary end points include DCR, pCR of Arm2, PFS , OS, safety. Recruitment is ongoing and will continue until 100 patients are enrolled. Clinical trial information: NCT06100497.

Clinical trial identification

NCT06100497; 2023-10-27.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.