Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

Fudan University

Status and phase: Active, not recruiting; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: IMRT to the nasopharynx and neck; Drug: Gemcitabine and Cisplatin Chemotherapy; Drug: Adjuvant chemotherapy with Capecitabine; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04517214

TRANSFORM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Toripalimab Combined with GP Arm

Experimental group

Description:

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

Treatment:

Drug: Toripalimab

Drug: Adjuvant chemotherapy with Capecitabine

Drug: Gemcitabine and Cisplatin Chemotherapy

Radiation: IMRT to the nasopharynx and neck

GP Arm

Active Comparator group

Description:

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

Treatment:

Drug: Adjuvant chemotherapy with Capecitabine

Drug: Gemcitabine and Cisplatin Chemotherapy

Radiation: IMRT to the nasopharynx and neck