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A multicenter, prospective, randomized controlled study of radiotherapy combined with teriprizumab versus radiotherapy alone in the treatment of elderly patients with locally advanced nasopharyngeal carcinoma

A multicenter, prospective, randomized controlled study of radiotherapy combined with teriprizumab versus radiotherapy alone in the treatment of elderly patients with locally advanced nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051031
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-15
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

Nasopharyngeal carcinoma

Interventions

experimental group:Teriprolizumab treatment

Sponsors

Jiangxi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The age is greater than or equal to 70 years old; 2. ECOG score 0-1; 3. WHO type II/III untreated nasopharyngeal carcinoma confirmed by histology/cytology; 4. Patients with stage III-IVA staged by AJCC 8th edition; 5. No other important related diseases (such as other tumors, serious heart, lung and central nervous system diseases, etc.); 6. Blood routine HB>=90g/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; 7. Biochemical tests meet the following criteria: BIL =50ml/min (Cockcroft-Gault formula); 8. Survival period >= 12 months; 9. No previous allergic reaction to biological agents is expected; 10. No bad habits such as drug use; 11. Those who are expected to have good compliance; 12. Voluntarily participate and sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. The patient has distant metastasis; 2. Patients with 2 or more tumors at the same time; 3. The patient has received head and neck radiotherapy or chemotherapy in the past; 4. Subjects who need to be given corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug; 5. Patients with severe allergic history or allergic constitution; active autoimmune diseases that may worsen when receiving immunostimulants. Patients with type 1 diabetes mellitus, vitiligo, psoriasis, or hypo- or hyperthyroid disease that do not require immunosuppressive therapy are eligible to participate in the study; 6. Immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related disease, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface antigen positive, or HCV RNA positive when anti-HCV antibody screening test is positive). have a known history of active tuberculosis (TB); 7. Serious infection (CTCAE>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging examination showed active pulmonary inflammation , Symptoms and signs of infection or need for oral or intravenous antibiotic treatment within 2 weeks before the first use of study drug (excluding prophylactic use of antibiotics); 8. Those who are considered inappropriate by the investigator to participate in this trial, such as severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent or active suicide) thoughts or behavior) or abnormal laboratory tests.

Design outcomes

Primary

MeasureTime frame
2-year progression-free survival rate;

Countries

China

Contacts

Public ContactLi Jingao, Chen Mingyuan

Jiangxi Cancer Hospital

lijingao@hotmail.com+86 13970866296

Outcome results

None listed

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