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Neoadjuvant treatment of nasopharyngeal carcinoma with carrilizumab combined with gemcitabine and cisplatin

Neoadjuvant treatment of nasopharyngeal carcinoma with carrilizumab combined with gemcitabine and cisplatin

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057745
Enrollment
Unknown
Registered
2022-03-16
Start date
2022-03-10
Completion date
Unknown
Last updated
2023-11-06

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:Immunotherapy combined with chemotherapy (GP regimen) + carrilizumab

Sponsors

West District of the First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Patients with N2 or N3 or T4 nasopharyngeal carcinoma confirmed by pathology or histology; 3. At least one measurable lesion (spiral CT >=10mm, meeting RECIST 1.1 criteria); 4. ECOG score: 0-1; 5. Expected survival >= 3 months; 6. If the major organs function normally, the following criteria are met: (1) The standard of routine blood examination shall meet (no blood transfusion or blood products within 14 days) : WBC >= 4x10^9 /L, HB>=90 g/L, ANC>=1.5x10^9/L, PLT>=80x10^9/L; (2) Biochemical examination should meet the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 7. The patients voluntarily joined the study and signed the informed consent with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Previous history of radiotherapy or chemotherapy; 2. History of immunodeficiency diseases; 3. Patients with severe uncontrollable infection; 4. High doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks; 5. Pregnancy or lactation; 6. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 7. A history of allergy to any component of carrilizumab, gemcitabine, cisplatin and other platinum-based drugs; 8. Other conditions considered by the researchers to be ineligible for inclusion.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Overall Survival; Progression Free Survival;Disease Control Rate;2-year Overall Survival (OS) Rate;Adverse Event;

Countries

China

Contacts

Public ContactGao Jin

West District of the First Affiliated Hospital of University of Science and Technology of China

gjyjzhc@163.com+86 15395005376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026