Nasopharyngeal Carcinoma Clinical Trial
Official title:
PD-1 Inhibitor Plus GP Chemotherapy as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Randomized Controlled Clinical Trial
The purpose of this Phase II, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.
Status | Not yet recruiting |
Enrollment | 146 |
Est. completion date | July 31, 2026 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III). 2. Original clinical staged as T4NanyM0 or TanyN2-3M0 (according to AJCC 8th edition), with no evidence of distant metastasis. 3. Eastern Cooperative Oncology Group performance status =1. 4. Adequate marrow function: neutrocyte count=1.5×10e9/L, hemoglobin =90g/L, and platelet count =100×10e9/L. 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) =1.5×upper limit of normal (ULN), and bilirubin = 1.5×ULN. 6. Adequate renal function: creatinine clearance rate = 60 ml/min (Cockcroft-Gault formula). 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Exclusion Criteria: 1. Age > 65 or < 18. 2. Receiving radiotherapy or chemotherapy or targeted therapy or immunotherapy previously. 3. Severe cerebrovascular disease/canker/psychosis. 4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 5. Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients who received systemic corticosteroid equivalent to prednisone =10mg/d, inhale or topical corticosteroid will be allowed. 6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed. 7. Suffering from active infection diseases and in need of treatment. 8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. 9. Pregnant or breastfeeding. 10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer and papillary thyroid carcinoma. 11. Has known allergy to large molecule protein products or any compound of PD-1 antibody. 12. Has a known history of the human immunodeficiency virus (HIV) infection. 13. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guangxi Medical University | Af?liated Hospital of North Sichuan Medical College, First People's Hospital of Yulin, Fourth Affiliated Hospital of Guangxi Medical University, Guigang People's Hospital, Hainan People's Hospital, LiuZhou People's Hospital, Wuhan Union Hospital, China, Wuzhou Red Cross Hospital, Yunnan Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure-free survival | the time from registration to treatment failure or death from any cause, whichever is first. | up to 24 months | |
Secondary | Complete Response (CR) | the complete disappearance of the target and non-target lesion identified at baseline after radiological evaluation by MRI. Disease response was evaluated after the completion of the neoadjuvant therapy, according to RECIST 1.1. | up to 9 weeks | |
Secondary | Overall survival | the time from registration to death due to any cause, or censored at date last known alive. | up to 24 months | |
Secondary | Locoregional failure-free survival(LRRFS) | the time from registration to the first locoregional relapse or death from any cause. | up to 24 months | |
Secondary | Distant metastasis-free survival(DMFS) | the time from registration to the first distant metastasis or death from any cause. | up to 24 months | |
Secondary | Adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 | up to 24 months | |
Secondary | Quality of life(QOL) | Assessed by European Organization for Research and Treatment of Cancer's quality of life questionnaire(QLQ)-C30 | up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05979961 -
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
|
Phase 3 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Recruiting |
NCT06055816 -
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT05547971 -
Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
|
||
Not yet recruiting |
NCT05020925 -
SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04547088 -
Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 2 | |
Not yet recruiting |
NCT04548271 -
Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT02795169 -
Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02569788 -
Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02801487 -
Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02237924 -
Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT02044562 -
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
|
N/A | |
Terminated |
NCT01694576 -
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
|
Phase 2 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01271439 -
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
|
Phase 2 | |
Completed |
NCT00535795 -
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
|
Phase 3 | |
Completed |
NCT00379262 -
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
|
Phase 3 | |
Completed |
NCT03398980 -
Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
|
N/A | |
Completed |
NCT01309633 -
Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)
|
Phase 2 |