Clinical Trials Logo

Clinical Trial Summary

In patients with locally advanced head and neck squamous cell carcinoma undergoing standard surgical treatment after neoadjuvant immunochemotherapy, can PD-1 inhibitor therapy be used instead of adjuvant radiotherapy for both primary and lymph node pathology? To provide further evidence-based medical evidence for the late precision treatment of HNSCC patients after neoadjuvant immunochemotherapy. Avoid the side effects caused by excessive radiotherapy, especially avoid the occurrence of second primary cancer, radiation osteonecrosis and other diseases. 1. Main study endpoint: A randomized controlled, non-inferiority, multicentre Phase III trial was conducted to investigate the difference in 5-year overall survival (OS) between experimental group (Group B) and control group (group A) in patients undergoing standard surgical treatment after neoadjuvant immunochemotherapy for locally advanced HNSCC, with both primary and lymph node pathology revealed by pCR. At the same time, adverse events and safety were evaluated according to NCI-CTCAE 5.0 criteria and RTOG later radiotherapy damage evaluation criteria. Safety indicators focused on late radiotherapy toxicity and the incidence of grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG. The differences in the incidence of grade 3 and 4 adverse events were compared between the experimental group and the control group. 2. Secondary study endpoint: The differences in 2-year disease-free survival (DFS), regional relapse-free survival (RRFS), distant metastasis free survival (DMFS), safety and adverse events were compared. Safety evaluation NCI-CTC AE 5.0 standard was used to evaluate the acute safety index of radiotherapy, and RTOG late-stage damage evaluation standard was used to evaluate the late-stage safety index of radiotherapy. 4) Exploratory goals The influence of prognostic laboratory indicators, clinical risk factors were analyzed. To explore the factors that influence the efficacy of radiotherapy after pCR immunotherapy.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05980715
Study type Interventional
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Jinsong Li, MD
Phone 008618583879908
Email caobleat@hotmail.com
Status Recruiting
Phase Phase 3
Start date January 1, 2023
Completion date December 31, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT03212742 - Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients Phase 1/Phase 2
Recruiting NCT06190782 - Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor Phase 3
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT05176002 - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Completed NCT01168479 - FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer Phase 3
Recruiting NCT03658343 - T2* MRI Analysis for Sarcoma N/A
Completed NCT03280719 - Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions N/A
Recruiting NCT05515796 - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors Phase 2
Recruiting NCT05514327 - A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL N/A
Recruiting NCT04453826 - Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma Phase 3
Recruiting NCT03370926 - FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy N/A
Active, not recruiting NCT03870919 - Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients N/A
Active, not recruiting NCT02428049 - Radiation Pneumonitis After SBRT for NSCLC
Recruiting NCT04923620 - Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy
Active, not recruiting NCT05371795 - Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device N/A
Recruiting NCT03210428 - Quantitative MR Imaging in Locally Advanced Cervical Cancer