PF chemotherapy combined with a PD-1/CTLA-4 bispecific antibody as first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma: a prospective, single-arm, phase II clinical study
- 1Department of Radiation Oncology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer Sichuan Cancer Center, Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China
- 2School of Medicine, University of Electronic Science and Technology of China
Abstract
Purpose: This study evaluated the antitumor activity and safety of cadonilimab, a programmed cell death protein 1 (PD-1)/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) bispecific antibody, combined with platinum/carboplatin and 5-fluorouracil (PF) chemotherapy as first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Methods: In this prospective, single-arm, phase II trial, patients with histopathologically confirmed R/M HNSCC received cadonilimab (10 mg/kg) plus PF chemotherapy every 3 weeks for 4–6 cycles, followed by maintenance cadonilimab. The primary endpoint was 1-year progression-free survival (PFS). A target sample size of 30 was planned, but the study was terminated prematurely after enrolling 16 patients due to slow accrual.
Results: Sixteen patients were enrolled. At a median follow-up of 18.4 months (range, 4.6 - 39.6), the 1-year PFS and overall survival (OS) rates were 50.0% (95% CI: 30.6% - 81.6%) and 75.0% (95% CI: 56.5% - 99.5%), respectively. The Objective Response Rate (ORR) was 56.3% (95% CI: 29.9% - 80.2%). Median PFS and OS were 9.8 months (95% CI: 2.8 - NR) and 17.7 months (95% CI: 12.3 - NR), respectively. Grade ≥3 treatment-related adverse events (TRAEs) occurred in four patients (25%), with no treatment-related deaths or immune-related cardiac toxicities reported.
Conclusion: In this exploratory study, first-line cadonilimab combined with PF chemotherapy exhibited potential antitumor activity and manageable safety profiles in patients with R/M HNSCC. Given the favorable baseline profile of the cohort and the single-arm design, these findings should be interpreted with caution. Larger randomized controlled trials are required to determine whether dual PD-1/CTLA-4 blockade offers an incremental benefit over standard anti-PD-1-based regimens.
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BibTeX
@article{liao2026chemotherapy,
title = {{PF chemotherapy combined with a PD-1/CTLA-4 bispecific antibody as first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma: a prospective, single-arm, phase II clinical study}},
author = {Wenjun Liao and Qiaohua Li and Yue Deng and Jun Zhang and Yue Zhao and Shichuan Zhang},
journal = {Frontiers in Oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1961360},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1961360/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - PF chemotherapy combined with a PD-1/CTLA-4 bispecific antibody as first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma: a prospective, single-arm, phase II clinical study
AU - Wenjun Liao
AU - Qiaohua Li
AU - Yue Deng
AU - Jun Zhang
AU - Yue Zhao
AU - Shichuan Zhang
PY - 2026
DA - 2026/10/22
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1961360
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1961360/full
AB - Purpose: This study evaluated the antitumor activity and safety of cadonilimab, a programmed cell death protein 1 (PD-1)/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) bispecific antibody, combined with platinum/carboplatin and 5-fluorouracil (PF) chemotherapy as first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Methods: In this prospective, single-arm, phase II trial, patients with histopathologically confirmed R/M HNSCC received cadonilimab (10 mg/kg) plus PF chemotherapy every 3 weeks for 4–6 cycles, followed by maintenance cadonilimab. The primary endpoint was 1-year progression-free survival (PFS). A target sample size of 30 was planned, but the study was terminated prematurely after enrolling 16 patients due to slow accrual. Results: Sixteen patients were enrolled. At a median follow-up of 18.4 months (range, 4.6 - 39.6), the 1-year PFS and overall survival (OS) rates were 50.0% (95% CI: 30.6% - 81.6%) and 75.0% (95% CI: 56.5% - 99.5%), respectively. The Objective Response Rate (ORR) was 56.3% (95% CI: 29.9% - 80.2%). Median PFS and OS were 9.8 months (95% CI: 2.8 - NR) and 17.7 months (95% CI: 12.3 - NR), respectively. Grade ≥3 treatment-related adverse events (TRAEs) occurred in four patients (25%), with no treatment-related deaths or immune-related cardiac toxicities reported. Conclusion: In this exploratory study, first-line cadonilimab combined with PF chemotherapy exhibited potential antitumor activity and manageable safety profiles in patients with R/M HNSCC. Given the favorable baseline profile of the cohort and the single-arm design, these findings should be interpreted with caution. Larger randomized controlled trials are required to determine whether dual PD-1/CTLA-4 blockade offers an incremental benefit over standard anti-PD-1-based regimens.
SN - 2234-943X
ER -