Clinical trial NCT04517214: Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma
Official title: Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Primary metastatic
de novo metastatic
Toripalimab
PD-1
Immune checkpoint inhibitor
Chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Fudan University Eye and ENT Hospital
name: Anhui Provincial Hospital
name: Sir Run Run Shaw Hospital
name: Hangzhou Cancer Hospital
name: Ningbo Medical Center Lihuili Hospital
name: The First People's Hospital of Changzhou
name: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Nanfang Hospital, Southern Medical University
name: Shenzhen People's Hospital
name: First Affiliated Hospital of Xi'anJiaotong Univerisity
name: Guangzhou Panyu Central Hospital
name: Fujian Cancer Hospital
First posted: 2020-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 year
Secondary outcomes:
measure: Objective Response Rate of Systemic chemotherapy
timeFrame: At the end of Cycle 6 of chemotherapy (each cycle is 21 days)
measure: Disease Control Rate of Systemic chemotherapy
timeFrame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
measure: The proportion of patients received radiotherapy to nasopharynx
timeFrame: 2 year
measure: Overall Survival
timeFrame: 5 year
measure: Progression-free Survival Rate
timeFrame: 1 year, 2 year rates
measure: Overall Survival Rate
timeFrame: 1 year, 2 year rates
measure: the Incidence of Adverse Effect
timeFrame: 1 year
measure: Changes of Quality of life, according to EORTC QLQ-C30
timeFrame: 1 year
measure: Changes of Quality of life, according to EORTC QLQ-H&N35
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaomin Ou
Study officials:
affiliation: Fudan University
name: Chaosu Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
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