The RADIANCE trial plans to enroll patients with chemotherapy-ineligible de novo metastatic nasopharyngeal carcinoma (AJCC 9th edition, TxNxM1). Participants will receive Radscopal radiotherapy, consisting of low-dose radiotherapy to the primary lesions and stereotactic body radiotherapy to distant metastatic lesions, in combination with sintilimab and ipilimumab. The study will evaluate the objective response rate of the primary lesions, systemic disease control as measured by progression-free survival and overall survival, and the safety and tolerability of this treatment regimen. The main questions this study aims to answer are: Does this treatment improve efficacy with acceptable safety in chemotherapy-ineligible patients? Does Radscopal radiotherapy enhance systemic antitumor immunity, and what is the Radscopal Response Rate? What clinical and immunological factors are associated with the Radscopal effect, and what mechanisms may underlie this effect?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Sintilimab 200 mg will be administered by intravenous infusion once every 2 weeks, starting within 7 days after completion of stereotactic body radiotherapy, until unacceptable toxicity, disease progression, or for up to 6 months.
Ipilimumab 1 mg/kg will be administered by intravenous infusion once every 6 weeks for 2 cycles, beginning on the same day as the first sintilimab infusion.
Participants will receive low-dose radiotherapy to the primary tumors at 8 Gy in 8 fractions. Stereotactic body radiotherapy will also be delivered to distant metastatic lesions at 24 Gy in 3 fractions.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Objective Response Rate (ORR) of Primary Lesions
The proportion of participants with confirmed complete response or partial response in measurable primary lesions (nasopharyngeal and neck), assessed according to RECIST version 1.1.
Time frame: 6 months
Objective Response Rate by Lesion Irradiation Type
The proportion of lesions achieving complete response or partial response among stereotactic body radiotherapy-treated, low-dose radiotherapy-treated, and non-irradiated lesions according to RECIST version 1.1.
Time frame: 6 months
Disease Control Rate (DCR)
The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame: 6 months
Duration of Response (DoR)
The time from first documented complete response or partial response to disease progression or death from any cause.
Time frame: 1 year
One-Year Progression-Free Survival (PFS)
Calculated from enrollment to the date of disease progression or death from any cause, whichever occurred first.
Time frame: 1 year
One-Year Overall Survival (OS)
Calculated from enrollment to the date of death from any cause.
Time frame: 1 year
Adverse Events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE version 5.0.
Time frame: 1 year
Quality of Life (QoL): EORTC QLQ-C30
Change in QoL from baseline will be assessed using the EORTC QLQ-C30 questionnaire. The questionnaire includes functional scales, symptom scales, a global health status scale, and single-item symptom scales. Scores will be calculated according to the EORTC scoring manual.
Time frame: 1 year
Quality of Life (QoL): EORTC QLQ-HN35
Change in head and neck cancer-specific QoL from baseline will be assessed using the EORTC QLQ-HN35 questionnaire. Scores will be calculated according to the EORTC scoring manual.
Time frame: 1 year
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