Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

July 25, 2021 updated by: Chaosu Hu, Fudan University

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

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 Overview

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 Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chaosu Hu, M.D.
  • Phone Number: 81400 +8621-64175590
  • Email: hucsu62@163.com

Study Contact Backup

Study Locations

      • Shanghai, China, 200032
        • Recruiting
        • Xiaomin Ou
        • Contact:
        • Principal Investigator:
          • Chaosu Hu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
PD-1 inhibitor
Other Names:
  • JS001
IMRT to the nasopharynx and neck
Other Names:
  • RT to the nasopharynx and neck
Systemic chemotherapy
Other Names:
  • GP regimen chemotherapy
Adjuvant chemotherapy after radiation
Other Names:
  • Xeloda
ACTIVE_COMPARATOR: 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
IMRT to the nasopharynx and neck
Other Names:
  • RT to the nasopharynx and neck
Systemic chemotherapy
Other Names:
  • GP regimen chemotherapy
Adjuvant chemotherapy after radiation
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate of Systemic chemotherapy
Time Frame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
ORR according to RECIST 1.1 Criteria
At the end of Cycle 6 of chemotherapy (each cycle is 21days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 15, 2020

First Posted (ACTUAL)

August 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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