Last updated: April 9, 2024
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Not Recruiting
Phase
2
Condition
Nasopharyngeal Cancer
Carcinoma
Treatment
Sintilimab, bevacizumab, gemcitabine
IMRT
Clinical Study ID
NCT06364826
NPC-202403
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Sign a written informed consent before implementing any procedures related to thetrial; 2. No gender limitation, age ≥18 years old, ≤75 years old; 3. Histological orcytological determination of advanced nasopharyngeal carcinoma assessed by theinvestigator without any treatment (stage III-IVA, except T3N0M0); 4. Not suitable forplatinum therapy (patients > 70 years old, PS > 2, hearing impairment, renalinsufficiency (creatinine clearance < 50ml/min) or grade 1 neuropathy;2023 CSCOGuidelines for the Diagnosis and Treatment of Head and Neck Tumors) or patients do notreceive platinum therapy; 5. The ECOG PS score is 0-1; 6. According to the solid tumorefficacy evaluation criteria (RECIST version 1.1), there is at least oneradiographically measurable lesion; 7. Expected survival time > 6 months; 8. Adequateorgan function.
Exclusion
Exclusion Criteria:
- Patients with uncured malignancies other than advanced nasopharyngeal carcinomadiagnosed within 5 years prior to initial administration (excluding radical basal cellcarcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma insitu after radical resection); 2. Is currently participating in an interventionalclinical study, or has received other investigational drugs or used investigationaldevices within 4 weeks prior to initial dosing; 3. Previous treatment with anti-PD-1,anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus orsynergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Previouslyreceived anti-angiogenic therapy, including but not limited to anti-angiogenicmonoclonal antibodies, anti-angiogenic TKI, etc.; 5. Received systemic systemictreatment with proprietary Chinese medicines with anti-tumor indications orimmunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeksbefore the first administration; 6. An active autoimmune disease requiring systemictreatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants)has occurred within 2 years prior to first administration.Replacement therapies (suchas thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitaryinsufficiency) are not considered systemic therapy; 7. Known allogeneic organtransplantation (except corneal transplantation) or allogeneic hematopoietic stem celltransplantation; 8. Known active ingredients or excipients of Sintilimab andbevacizumab in this study, and allergic patients to chemotherapy drugs in this study;
- Has not fully recovered from toxicity and/or complications caused by anyintervention before starting treatment (i.e., ≤ grade 1 or baseline, excludingweakness or hair loss); 10. Known history of human immunodeficiency virus (HIV)infection (i.e. HIV 1/2 antibody positive); 11. Other researchers did not consider itappropriate to study enrollment
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Sintilimab, bevacizumab, gemcitabine
Phase: 2
Study Start date:
April 22, 2024
Estimated Completion Date:
April 22, 2026