Clinical Trials Logo

Clinical Trial Summary

This study sought to investigate the efficacy and safety of a three-drug combination antiemetic regimen of olanzapine combined with aprepitant and palonosetron for the prevention of chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma.


Clinical Trial Description

Intensity modulated radiotherapy (IMRT) combined with high-dose cisplatin is the standard treatment for locally advanced head and neck squamous cell carcinoma. Previous clinical studies of concurrent chemoradiotherapy have shown that the incidence of nausea and vomiting after treatment with 5-HT3RA and dexamethasone is about 40%. Nausea and vomiting seriously affect the patient's treatment tolerance and quality of life. In our previous prospective phase 2 study (NCT03572829), the triple antiemetic regimen of NK-1R antagonist (aprepitant), dexamethasone and ondansetron was firstly used in patients with head and neck squamous cell carcinoma who received concurrent chemoradiotherapy. the primary endpoint-complete response rate was 86%, and the incidence of no vomiting was 88.4%, which was better than the data previously reported in the literatures. The incidence of no nausea was only 60.5%, and the hiccup caused by dexamethasone was as high as 16%. And with the confirmation of the efficacy of immunotherapy in head and neck squamous cell carcinoma, the use of dexamethasone may reduce immunotherapy. Therefore, it is necessary to further optimize the antiemetic regimen. In recent years, a number of randomized studies have confirmed that the addition of olanzapine can reduce the incidence of nausea and increase the complete response rate of high emetic chemotherapy. Other randomized studies have shown that in patients with malignant tumors (including head and neck squamous cell carcinoma and esophageal cancer) receiving concurrent chemoradiotherapy, the NK-1R antagonist was changed to olanzapine on the basis of the original triple regimen, which significantly redeced the incidence of nausea. Therefore, on the basis of previous studies, this study intends to conduct a prospective, single-arm phase II study to explore the efficacy and safety of olanzapine combined with aprepitant and palonosetron in the prevention of nausea and vomiting in patients with locally advanced head and neck squamous cell carcinoma receiving IMRT and concurrent chemotherapy.. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05202275
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Zekun Wang, MD
Phone +8618710221130
Email [email protected]
Status Recruiting
Phase Phase 2
Start date December 1, 2020
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With a PD-1 Inhibitor Phase 1/Phase 2
Recruiting NCT03317327 - REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors Phase 1/Phase 2
Recruiting NCT04854499 - Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma Phase 2
Not yet recruiting NCT05031910 - Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality N/A
Recruiting NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Not yet recruiting NCT05322135 - A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma Early Phase 1
Active, not recruiting NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT03665285 - A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04045496 - A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04452214 - A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors Phase 1
Recruiting NCT04096638 - Evaluating Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT03070366 - Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC Phase 2
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02488629 - Study of SCB01A in Patient With Head and Neck Cancer Phase 2
Completed NCT01697800 - A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract Phase 2
Completed NCT01427478 - Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck Phase 3
Recruiting NCT05065086 - Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
Active, not recruiting NCT02567422 - Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer Phase 1
Completed NCT03022409 - A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC). Phase 1