Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma

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

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 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:

    1. 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;
  1. 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

Study Description

Platinum deplatinization has been extensively explored in patients with posterior nasopharyngeal carcinoma who have received multiple platinum treatments, including target-free combination, GEP, etc. Our center also published in 2022 CSCO a study on the preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line treatment of metastatic NPC with or without cisplatin or anlotinib. Enrolled patients were treated with pembrolizumab + anlotinib +GP (group A), pembrolizumab +GP (group B), and pembrolizumab + anlotinib +G (group C), with ORR of 80% (4/5), 80% (4/5), and 100% (7/7), respectively. Among them, there were 1 CR and 6 PR in group C. Compared to group B, group C with anlotinib in place of cisplatin showed a better safety profile with fewer grade 3 adverse reactions (57.1% vs 100%). In summary, we designed this study to evaluate the efficacy and safety of gemcitabine, sintilimab and bevacizumab combined with IMRT in patients with advanced nasopharyngeal carcinoma not suitable for platinum-based treatment, and to explore new therapeutic approaches for patients with advanced stage nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive platinum therapy.

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.