Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT04517214

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

PD-1 inhibitor

IMRT to the nasopharynx and neck

Intervention Type: RADIATION

IMRT to the nasopharynx and neck

Gemcitabine and Cisplatin Chemotherapy

Intervention Type: DRUG

Systemic chemotherapy

Adjuvant chemotherapy with Capecitabine

Intervention Type: DRUG

Adjuvant chemotherapy after radiation

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

Group Type: ACTIVE_COMPARATOR

IMRT to the nasopharynx and neck

Intervention Type: RADIATION

IMRT to the nasopharynx and neck

Gemcitabine and Cisplatin Chemotherapy

Intervention Type: DRUG

Systemic chemotherapy

Adjuvant chemotherapy with Capecitabine

Intervention Type: DRUG

Adjuvant chemotherapy after radiation

Interventions

Toripalimab

PD-1 inhibitor

Intervention Type: DRUG

IMRT to the nasopharynx and neck

IMRT to the nasopharynx and neck

Intervention Type: RADIATION

Gemcitabine and Cisplatin Chemotherapy

Systemic chemotherapy

Intervention Type: DRUG

Adjuvant chemotherapy with Capecitabine

Adjuvant chemotherapy after radiation

Intervention Type: DRUG

Other Intervention Names

JS001; RT to the nasopharynx and neck; GP regimen chemotherapy; Xeloda

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University Eye and ENT Hospital

UNKNOWN

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Hangzhou Cancer Hospital

OTHER

Sponsor Role: collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role: collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role: collaborator

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

OTHER

Sponsor Role: collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Xi'anJiaotong Univerisity

UNKNOWN

Sponsor Role: collaborator

Guangzhou Panyu Central Hospital

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chaosu Hu

Vice Director of Department of Radiation Oncology, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chaosu Hu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Xiaomin Ou

Shanghai, , China

Countries

China

References

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Other Identifiers

TRANSFORM

Identifier Type: -

Identifier Source: org_study_id