Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- IMRT to the nasopharynx and neck
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Chaosu Hu
Vice Director of Department of Radiation Oncology, Clinical Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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);
Exclusion Criteria
- •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;
Arms & Interventions
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: IMRT to the nasopharynx and neck
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: Toripalimab
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: IMRT to the nasopharynx and neck
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: Gemcitabine and Cisplatin Chemotherapy
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: Adjuvant chemotherapy with Capecitabine
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: Gemcitabine and Cisplatin Chemotherapy
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
Intervention: Adjuvant chemotherapy with Capecitabine
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 5 year
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
Secondary Outcomes
- Objective Response Rate of Systemic chemotherapy(At the end of Cycle 6 of chemotherapy (each cycle is 21 days))
- Disease Control Rate of Systemic chemotherapy(At the end of Cycle 6 of chemotherapy (each cycle is 21days))
- The proportion of patients received radiotherapy to nasopharynx(2 year)
- Overall Survival(5 year)
- Progression-free Survival Rate(1 year, 2 year rates)
- Overall Survival Rate(1 year, 2 year rates)
- the Incidence of Adverse Effect(1 year)
- Changes of Quality of life, according to EORTC QLQ-C30(1 year)
- Changes of Quality of life, according to EORTC QLQ-H&N35(1 year)