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?
1. Age 18-80 years.
2. Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma (TxNxM1 according to AJCC 9th edition), with ≤10 measurable metastatic lesions.
3. At least one measurable nasopharyngeal lesion suitable for low-dose radiotherapy and at least one distant metastatic lesion suitable for stereotactic body radiotherapy.
4. ECOG performance status 0-2.
1. Age <18 years.
2. >10 metastatic lesions, meningeal metastasis, spinal cord compression, or lesions unsuitable for safe stereotactic body radiotherapy.
3. Other malignancy within 5 years, except cured basal cell carcinoma, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or cervical carcinoma in situ.
4. Prior systemic immune checkpoint inhibitor therapy or prior nasopharyngeal radiotherapy.
Single group
Sintilimab
DrugSintilimab 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
DrugIpilimumab 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.
Radscopal Radiotherapy
RadiationParticipants 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.
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.
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.
Disease Control Rate (DCR)
The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1.
Duration of Response (DoR)
The time from first documented complete response or partial response to disease progression or death from any cause.
One-Year Progression-Free Survival (PFS)
Calculated from enrollment to the date of disease progression or death from any cause, whichever occurred first.
Objective Response Rate (ORR) by Prespecified Subgroups
ORR will be summarized in prespecified subgroups defined by number of metastatic lesions, PD-L1 CPS level, metastatic pattern, and baseline plasma EBV DNA level.
Immune cell subsets of tissue samples
Relative abundance and activation status of immune cell subsets in tumor tissue will be assessed by single-cell RNA sequencing of fresh biopsy samples and compared between responders and non-responders.
Serum cytokine levels
Changes in Serum cytokine levels will be measured using a serum cytokine assay in serial peripheral blood samples to explore systemic immune response throughout the study.
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
