Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

Brief Title

Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

Official Title

Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Response Rate of Systemic chemotherapy

Secondary Outcome

 Disease Control Rate of Systemic chemotherapy

Condition

Nasopharyngeal Carcinoma

Intervention

Toripalimab

Study Arms / Comparison Groups

 Toripalimab Combined with GP Arm

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 1, 2020

Completion Date

December 31, 2026

Primary Completion Date

December 31, 2024

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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Xiaomin Ou, M.D., +8621-64175590, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04517214

Organization ID

TRANSFORM

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Collaborators

 Fudan University Eye and ENT Hospital

Study Sponsor

Xiaomin Ou, M.D., Study Director, Fudan University

Verification Date

August 2020