Status:
ACTIVE_NOT_RECRUITING
Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Fudan University Eye and ENT Hospital
Anhui Provincial Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Sign an informed consent;
- Age older than 18 years old and younger than 70 years old;
- Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma;
- At least one metastatic site that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
- Anticipated overall survival more than 3 months;
- Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
- No primary treatment of radiation, surgery, chemotherapy, targeted therapy and immune therapy post diagnosis of NPC;
- Neutrophil ≥ 1.5×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L;
- With normal liver function test (ALT、AST ≤ 3×ULN, TBIL≤ 1.5×ULN, Albumin≥2.8g/dL );
- With normal renal function test (Creatinine ≤ 1.5 ×ULN and creatinine clearance ≥60 ml/min);
- HBV DNA\<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- Male and no pregnant female, able to adapt birth control methods during treatment.
Exclusion
- Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine;
- Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
- Necrotic disease, high-risk of massive nasal bleeding;
- Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- Receive vaccine or live vaccine within 30 days prior to signing the informed consent;
- Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
- Severe, uncontrolled medical conditions and infections;
- 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;
- History of interstitial lung disease;
- HIV positive;
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- 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;
- Women of child-bearing potential who are pregnant or breastfeeding.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04517214
Start Date
November 1 2020
End Date
December 31 2026
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xiaomin Ou
Shanghai, China, 200032