Clinical study on efficacy and safety of Tirellizumab combined with chemoradiotherapy in high-risk locally advanced nasopharyngeal carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084683

Enrollment

Unknown

Registered

2024-05-22

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-05-27

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:Induction chemotherapy stage: Tirellizumab combined with GP regimen chemotherapy Adjuvant chemotherapy stage: Tirelizumab combined with capecitabine

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Non-keratinized nasopharyngeal carcinoma was confirmed by histology (WHO pathological type II or III); 2.AJCC/UICC (8th edition) patients with stage III-IVa (excluding T3N0-1); 3. Age 18-70 years old; 4.ECOG score 0-1; 5. White blood cells =4× 109/L, platelet PLT=100× 109/L, hemoglobin =90g/L; 6. Normal liver function (TBIl, ALT, AST=2.5 ×ULN); 7. Normal renal function (Ccr=60ml/min or creatinine =1.5 ×ULN); 8. Thyroid, adrenal and pituitary functions are normal; 9. Informed consent signed by myself or legal representative.

Exclusion criteria

Exclusion criteria: 1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I); 2. age > 70 years old or < 18 years old; 3. No induction chemotherapy or radical chemoradiotherapy; 4. The primary tumor or lymph node has received chemotherapy or surgery (except for diagnostic procedures); 5. Previous history of malignant tumors, except for treated basal cell or squamous cell skin cancer and in situ cervical cancer; 6. Previously received chemotherapy, targeted therapy, immunotherapy and other systemic anti-tumor treatment; 7. Previous history of radiation therapy; 8. Pregnancy or lactation (for women of childbearing age, pregnancy tests are carried out and effective contraception is emphasized during treatment); 9. Have immunotherapy-related underlying diseases and active infections; 10. Mental patients or those who are completely unable to cooperate in treatment.

Design outcomes

Primary

Measure	Time frame
Complete Response Rate;Safety;	—

Secondary

Measure	Time frame
Objective Response Rate;1-year regional relapse-free survival rate;The 1-year survival rate without distant metastasis;1-year failure-free survival rate;Failure-free lifetime;Overall Survival;	—

Countries

China

Contacts

Public ContactDuan He-Xin

Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital

dhx7530@163.com+86 187 9744 8085

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026