Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

Phase 2

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Toripalimab; Radiation: IMRT to the nasopharynx and neck; Drug: Gemcitabine and Cisplatin Chemotherapy; Drug: Adjuvant chemotherapy with Capecitabine

• Registration Number: NCT04517214
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-18
• Study Start: 2020-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toripalimab Combined with GP Arm	IMRT to the nasopharynx and neck	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
Toripalimab Combined with GP Arm	Gemcitabine and Cisplatin Chemotherapy	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
Toripalimab Combined with GP Arm	Adjuvant chemotherapy with Capecitabine	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
GP Arm	IMRT to the nasopharynx and neck	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
GP Arm	Gemcitabine and Cisplatin Chemotherapy	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
GP Arm	Adjuvant chemotherapy with Capecitabine	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
Toripalimab Combined with GP Arm	Toripalimab	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival	5 year	PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate of Systemic chemotherapy	At the end of Cycle 6 of chemotherapy (each cycle is 21 days)	ORR according to RECIST 1.1 Criteria
Disease Control Rate of Systemic chemotherapy	At the end of Cycle 6 of chemotherapy (each cycle is 21days)	DCR according to RECIST 1.1 Criteria
The proportion of patients received radiotherapy to nasopharynx	2 year	Only patients with disease control after systemic chemotherapy will receive radiotherapy
Overall Survival	5 year	Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Progression-free Survival Rate	1 year, 2 year rates	Defined from date of randomization to date of first documentation of progression or death due to any cause.
Overall Survival Rate	1 year, 2 year rates	Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
the Incidence of Adverse Effect	1 year	According to CTCAE 4.0.03
Changes of Quality of life, according to EORTC QLQ-C30	1 year	According to EORTC QLQ-C30
Changes of Quality of life, according to EORTC QLQ-H&N35	1 year	According to EORTC QLQ-H\&N35

Trial Locations

Locations (1)

Xiaomin Ou; 🇨🇳 Shanghai, China