Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Primary metastatic, de novo metastatic, Toripalimab, PD-1, Immune checkpoint inhibitor, Chemotherapy
Brief summary
The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Detailed description
About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Interventions
DRUGToripalimab
PD-1 inhibitor
RADIATIONIMRT to the nasopharynx and neck
IMRT to the nasopharynx and neck
Systemic chemotherapy
DRUGAdjuvant chemotherapy with Capecitabine
Adjuvant chemotherapy after radiation
Sponsors
Fudan University Eye and ENT Hospital
Anhui Provincial Hospital
Sir Run Run Shaw Hospital
Hangzhou Cancer Hospital
Ningbo Medical Center Lihuili Hospital
The First People's Hospital of Changzhou
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nanfang Hospital, Southern Medical University
Shenzhen People's Hospital
First Affiliated Hospital of Xi'anJiaotong Univerisity
Guangzhou Panyu Central Hospital
Fujian Cancer Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Sign an informed consent; 2. Age older than 18 years old and younger than 70 years old; 3. Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma; 4. At least one metastatic site that fulfills the criteria of Evaluable Disease per RECIST 1.1 Criteria; 5. Anticipated overall survival more than 3 months; 6. Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1; 7. No primary treatment of radiation, surgery, chemotherapy, targeted therapy and immune therapy post diagnosis of NPC; 8. Neutrophil ≥ 1.5×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L; 9. With normal liver function test (ALT、AST ≤ 3×ULN, TBIL≤ 1.5×ULN, Albumin≥2.8g/dL ); 10. With normal renal function test (Creatinine ≤ 1.5 ×ULN and creatinine clearance ≥60 ml/min); 11. HBV DNA\<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ; 12. Male and no pregnant female, able to adapt birth control methods during treatment.
Exclusion criteria
1. Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine; 2. Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation; 3. Necrotic disease, high-risk of massive nasal bleeding; 4. Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years; 5. Receive vaccine or live vaccine within 30 days prior to signing the informed consent; 6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent; 7. Severe, uncontrolled medical conditions and infections; 8. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy; vitiligo or inactive asthma who don't need systemic therapy can recruit; 9. History of interstitial lung disease; 10. HIV positive; 11. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA; 12. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors; 13. Women of child-bearing potential who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 year | PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate of Systemic chemotherapy | At the end of Cycle 6 of chemotherapy (each cycle is 21days) | DCR according to RECIST 1.1 Criteria |
| The proportion of patients received radiotherapy to nasopharynx | 2 year | Only patients with disease control after systemic chemotherapy will receive radiotherapy |
| Overall Survival | 5 year | Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. |
| Progression-free Survival Rate | 1 year, 2 year rates | Defined from date of randomization to date of first documentation of progression or death due to any cause. |
| Objective Response Rate of Systemic chemotherapy | At the end of Cycle 6 of chemotherapy (each cycle is 21 days) | ORR according to RECIST 1.1 Criteria |
| the Incidence of Adverse Effect | 1 year | According to CTCAE 4.0.03 |
| Changes of Quality of life, according to EORTC QLQ-C30 | 1 year | According to EORTC QLQ-C30 |
| Changes of Quality of life, according to EORTC QLQ-H&N35 | 1 year | According to EORTC QLQ-H&N35 |
| Overall Survival Rate | 1 year, 2 year rates | Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. |
Countries
China
Outcome results
None listed