Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Cancer Hospital of Guizhou Province
Hunan Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the efficacy and safety of a combination of GP chemotherapy and tislelizumab in neoadjuvant therapy combined with tislelizumab in adjuvant therapy of locoregion...
Detailed Description
Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma(NPC). Gemcitabine plus cisplatin(GP) has been demonstrated an eff...
Eligibility Criteria
Inclusion
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Age ≥ 18 years and ≤70 years,men or non-pregnant women.
- Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
- Tumor staged as III-IVA (AJCC 8th, except T3N0，T3N1(Only retropharyngeal lymph nodes metastasized).
- No previous anti-tumor treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Adequate marrow function:White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
Exclusion
- Patients with recurrent or metastatic nasopharyngeal carcinoma.
- Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
- Prior therapy with radiation or systemic chemotherapy.
- Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
- Seropositivity for human immunodeficiency virus (HIV).
- Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
- Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies.
- Patients with immunodeficiency disease or a history of organ transplantation.
- Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks.
- Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
- Patients with severe, uncontrolled disease or infections.
- Received other research drugs or in other clinical trials at the same time.
- Refuse or fail to sign the informed consent .
- Patients with other treatment contraindications.
- Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
- Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml.
- Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative.
- Patients who were known to be intolerable or allergic to treatment drug.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05211232
Start Date
June 10 2022
End Date
May 30 2028
Last Update
April 18 2024
Active Locations (4)
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1
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
2
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
3
Guizhou Cancer Hospital
Guiyang, Guizhou, China
4
Hunan Cancer Hospital
Changsha, Hunan, China