To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \[CR\]/partial response \[PR\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.
In a prospective clinical trial, under full-course immunotherapy, a platinum-based chemotherapy combined with immunotherapy regimen is used as the induction treatment protocol. Patients with stage Ⅳa (AJCC 8th,) nasopharyngeal carcinoma who achieve partial response (PR) or complete response (CR) after induction treatment, with EBV DNA reduced to zero or below the lower limit of detection, are randomized at a 1:1 ratio. One group receives reduced-dose radiotherapy combined with concurrent chemoimmunotherapy, while the other group receives conventional-dose radiotherapy combined with concurrent chemoimmunotherapy. Through follow-up, the differences in survival prognosis, incidence of complications, and quality of life between the two groups are observed. The aim is to evaluate whether, on the premise of ensuring non-inferior 3-year progression-free survival (PFS), reduced-dose radiotherapy shows superiority or significant improvement in ≥ grade 3 radiotherapy-related toxicities (especially xerostomia, dysphagia, and hearing loss) and quality of life. Thereby, it explores whether the treatment strategy of further reduced-dose radiotherapy is suitable for patients with locally advanced nasopharyngeal carcinoma who achieve CR/PR on imaging evaluation and have EBV DNA reduced to zero after neoadjuvant therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
456
Toripalimab 240 mg, once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.
Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.
GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy
GTVnx/nd:63.6Gy/30Fr/2.12Gy CTV1: 54Gy/30Fr/1.8Gy CTV2: 49.2Gy/30Fr/1.64Gy
Cisplatin 100mg/m2 every 3 weeks for 2 cycles
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGCancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University cancer center
Guangzhou, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of Sun Yat-sen University (SYSU)
Guangzhou, Guangdong, China
RECRUITINGCancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGZhongshan City People's Hospital
Zhongshan, Guangdong, China
RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
RECRUITINGTongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGCentral South University Cancer Hospital
Changsha, Hunan, China
RECRUITING...and 2 more locations
Progress-Free Survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time frame: 3 years
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Time frame: 3 years
Objective Response Rate (ORR)
Defined as the proportion of patients with tumor reduction achieving complete response (CR) or partial response (PR), assessed at 3 months after the end of concurrent chemoradiotherapy.
Time frame: assessed at 3 months after the end of concurrent chemoradiotherapy
The proportion of patients with treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 1 year
The proportion of patients with treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.