Abstract 392TiP
Background
Hypopharyngeal cancer is relatively rare, accounting for only 3% of head and neck cancers. A majority of the patients (pts) present at an advanced stage with a 5-year overall survival of 40%. Despite improvement in local regional control with neoadjuvant therapy, distant metastasis led to poor outcomes in hypopharyngeal cancer. Individualized adjuvant therapy based on pathologic complete response (pCR) and CD8+ T cell infiltration may be a promising strategy for pts after neoadjuvant therapy. Thus, we conducted a phase II study (ChiCTR2200055939) to evaluate the efficacy and safety of neoadjuvant and individualized adjuvant therapy and explore the correlation between tertiary lymphoid structures (TLS) and efficacy/immune microenvironment in pts with locally advanced hypopharyngeal cancer.
Trial design
In the prospective, open-label, single-arm phase II study, pts who have histologically or cytologically confirmed stage II-IVa hypopharyngeal cancer without recurrent/metastatic disease, ECOG performance status of 0-1, and predicted survival >3 months are eligible. Pts will intravenously receive 2-cycle neoadjuvant therapy with pembrolizumab (200 mg), albumin-bound paclitaxel (260 mg/m2), and cisplatin (100 mg/m2) on day 1 every 3 weeks. Surgical resection will be scheduled within 21-28 days after the final dose of neoadjuvant therapy. If postoperative pathology shows a pCR, pembrolizumab will be given as adjuvant therapy for 15 cycles. Pts with non-pCR but CD8+ cell density increased ≥20% from baseline will receive adjuvant radiotherapy (50-60Gy) plus pembrolizumab for 15 cycles; otherwise, non-pCR pts will withdraw from the study and receive conventional concurrent chemoradiotherapy. The primary endpoint is 12-month recurrence-free survival (RFS). Secondary endpoints are 18- and 24-month RFS, median RFS, pCR rate, and safety. Exploratory endpoints include the correlation between TLS and pathological response/RFS/immune microenvironment (eg, CD8+ cells, B/T lymphocytes). The phase 2 trial is ongoing.
Clinical trial identification
ChiCTR220005593p.
Legal entity responsible for the study
The Sixth Medical Center of Chinese PLA General Hospital.
Funding
Wu Jieping Medical Foundation.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
193P - Impact of coronavirus disease 2019 on patients with unresectable hepatocellular carcinoma treated with atezolizumab/bevacizumab
Presenter: Hongjae Chon
Session: Poster Display
Resources:
Abstract
194P - Real-world outcomes of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus chemotherapy as first-line treatment in advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS≤5
Presenter: Qi Xu
Session: Poster Display
Resources:
Abstract
195P - Ferroptosis signatures in pancreatic ductal adenocarcinomas and their role in patient survival: A translational unsupervised clustering analysis
Presenter: Quoc-Huy Trinh
Session: Poster Display
Resources:
Abstract
196P - Clinical significance of circulating CD8+ and CD4+ T cell proliferation in advanced gastric cancer receiving first-line chemotherapy
Presenter: In-Ho Kim
Session: Poster Display
Resources:
Abstract
197P - Treatment patterns and clinical outcomes of patients with unresectable advanced or metastatic (UAM) gastric/gastroesophageal junction adenocarcinoma (GA/GEJA) in China: A multicenter real-world study
Presenter: Yanqiao Zhang
Session: Poster Display
Resources:
Abstract
198P - Effectiveness of lenvatinib in patients with unresectable hepatocellular carcinoma: A multicenter observational study in Japan
Presenter: Namiki Izumi
Session: Poster Display
Resources:
Abstract
199P - Efficacy of endostar in combination with concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of esophagus: A randomized, open-label, phase II trial
Presenter: Yuexiao Qi
Session: Poster Display
Resources:
Abstract
200P - Prognosis of patients with hepatocellular carcinoma treated with transarterial chemoembolization: Development and validation of the ALFP score
Presenter: Baocuo Gong
Session: Poster Display
Resources:
Abstract
201P - A phase II study of serplulimab (a programmed death-1 inhibitor) with or without HLX04 (a bevacizumab biosimilar) for the treatment of advanced hepatocellular carcinoma
Presenter: Zhenggang Ren
Session: Poster Display
Resources:
Abstract
202P - Comparison of liver injury after transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy for intermediate and advanced hepatocellular carcinoma
Presenter: Yongru Chen
Session: Poster Display
Resources:
Abstract