Skip to content

Safety and efficacy of SBRT followed by PD-1 inhibitor Tirellizumab and GP regimen in first-line treatment of unresectable recurrent nasopharyngeal carcinoma

Safety and efficacy of SBRT followed by PD-1 inhibitor Tirellizumab and GP regimen in first-line treatment of unresectable recurrent nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084390
Enrollment
Unknown
Registered
2024-05-15
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

nasopharyngeal carcinoma

Interventions

SBRT group:SBRT

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Local and/or regional recurrence were occured more than one year after radiotherapy, and unfit for operation; 2) Aged 18-70years; 3) Local and/or regional recurrence were histopathologically proven; 4) Clinical stage was defined as rII- IVa according to the eight edition of the AJCC; 5) KPS>70 or ECOG 0-1; 6) No radiotherapy for recurrent lesion, chemotherapy, immunotherapy, etc. 7) No contraindications for chemotherapy, immunotherapy and radiotherapy; 8) Adequate bone marrow/liver and kidney function reserve is expected to successfully complete immunotherapy and chemotherapy; 9) Understanding the study and signing the informed consent form; 10) Completing research related questionnaire survey as required.

Exclusion criteria

Exclusion criteria: 1) With other malignancies; 2) Severe digestive disease; 3)Severe cardiopulmanary, liver and kidney dysfunction; 4) Previously received PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1; 5) With autoimmune disease or immune deficiency; 6)Vulnerable groups,including peaple with mental illness, with cgnitive impairment, critically ill patients, minors, pregnant women, etc; 7) Allergic to any PD-1 antibody component or macromolecular protein;

Design outcomes

Primary

MeasureTime frame
1-year local/ regional recurrence free survival rate;Progression free survival;

Secondary

MeasureTime frame
Objective response rate;1-year overall survival rate;Quality of life;safety;

Countries

China

Contacts

Public ContactWang Fangzheng

Zhejiang Cancer Hospital

wangfz@zjcc.org.cn+86 137 5718 6859

Outcome results

None listed

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