SBRT combined with chemotherapy and immunotherapy for multiple matastatic nasopharyngeal carcinoma

Safety and efficacy of low-fraction SBRT combined with GP regimen and PD-1 inhibitor toripalimab as first-line treatment for multiple metastatic nasopharyngeal carcinoma: a prospective, randomized controlled, single-center, phase III clinical study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110015

Enrollment

Unknown

Registered

2025-09-28

Start date

2025-10-06

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple metastatic nasopharyngeal carcinoma

Interventions

Treatment group:SBRT

Control group:No

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.The patient was diagnosed with nasopharyngeal carcinoma through pathological examination. At least 6 months after the first-line treatment of radiotherapy and chemotherapy, more than 3 tumor meastases occurred; 2.Not suitable for local treatment regimens, such as surgery, radiotherapy or TACE; 3.Aged 18 to 70 years; 4.PS 0 to 1; 5.There is at least one measurable metastatic lesion; 6.The expected survival period exceeds six months; 7.Has not received radiotherapy, chemotherapy, immunotherapy or targeted and other anti-tumor treatments for recurrent nasopharyngeal carcinoma in the pastt; 8.There are no contraindications for chemotherapy, immunotherapy or radiotherapy; 9.Sufficient reserves of bone marrow/ live and kidney functions are expected to enable the successful completion of immunization and chemotherapy; 10.Be able to understand this research and have signed the informed consent form; 11.Be able to complete the questionnaires related to the research as required;

Exclusion criteria

Exclusion criteria: 1.Also suffering from other malignant tumors; 2.Severe digestive system diseases; 3.Severe abnormalities in heart, lung, liver and kidney functions; 4.Previously received PD-1 antibody therapy or other immunotherapies targeting PD-1/PD-L1; 5.Suffering from autoimmune function deficiencies; 6.Vulnerable groups, including those with mental illness, cognitive inpairment, critically ill patients, minors, pregnant women, etc; 7.Allergic to any PD-1 antibody component or macromolecular protein;

Design outcomes

Primary

Measure	Time frame
One year Progression Free Survival, PFS;	—

Secondary

Measure	Time frame
Overall survival, OS;Objective response rate, ORR;	—

Countries

China

Contacts

Public ContactWang Fangzheng

Zhejiang Cancer Hospital

wangfz@zjcc.org.cn+86 571 8812 8192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026