Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

March 28, 2025 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chaosu Hu, M.D.
  • Phone Number: 81400 +8621-64175590
  • Email: hucsu62@163.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200032
        • Xiaomin Ou

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Toripalimab
PD-1 inhibitor
Other Names:
  • JS001
Radiation: IMRT to the nasopharynx and neck
IMRT to the nasopharynx and neck
Other Names:
  • RT to the nasopharynx and neck
Drug: Gemcitabine and Cisplatin Chemotherapy
Systemic chemotherapy
Other Names:
  • GP regimen chemotherapy
Drug: Adjuvant chemotherapy with Capecitabine
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
Radiation: IMRT to the nasopharynx and neck
IMRT to the nasopharynx and neck
Other Names:
  • RT to the nasopharynx and neck
Drug: Gemcitabine and Cisplatin Chemotherapy
Systemic chemotherapy
Other Names:
  • GP regimen chemotherapy
Drug: Adjuvant chemotherapy with Capecitabine
Adjuvant chemotherapy after radiation
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 year
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
5 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Objective Response Rate of Systemic chemotherapy
Time Frame: At the end of Cycle 6 of chemotherapy (each cycle is 21 days)
ORR according to RECIST 1.1 Criteria
At the end of Cycle 6 of chemotherapy (each cycle is 21 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fujian Cancer Hospital
Ningbo Medical Center Lihuili Hospital
Shenzhen People's Hospital
Hangzhou Cancer Hospital
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sir Run Run Shaw Hospital
Anhui Provincial Hospital
Guangzhou Panyu Central Hospital
The First People's Hospital of Changzhou
Fudan University Eye and ENT Hospital
First Affiliated Hospital of Xi'anJiaotong Univerisity
Nanfang Hospital, Southern Medical University
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chaosu Hu, M.D., Fudan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRANSFORM (Other Identifier: Indivior)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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