drugset / Trial / NCT06494943
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Timeline
- Start
- 2024-06-26
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Publications
- Background Ou X, Zhai R, Wei W, Chen J, Ou D, Liao T, Xu T, Zhu Y, Wang Y, Huang S, Shi R, Wu B, Chen T, Li Y, Yang Z, Zhou C, Liu Y, Jiang Z, Zeng M, Liu X, Ji D, Ying H, Zhang Z, Hu C, Lu X, Ji Q, He X, Wang Y. Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial. Clin Cancer Res. 2024 Jan 17;30(2):344-355. doi: 10.1158/1078-0432.CCR-23-2398.
- Background Long L, Zhang X, Chen F, Pan Q, Phiphatwatchara P, Zeng Y, Chen H. The promising immune checkpoint LAG-3: from tumor microenvironment to cancer immunotherapy. Genes Cancer. 2018 May;9(5-6):176-189. doi: 10.18632/genesandcancer.180.
- Background Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | NEGALSTOBART | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 150 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |