Toripalimab and Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma.

February 2, 2023 updated by: Ming-Yuan Chen, Sun Yat-sen University

Toripalimab Combined With Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma

This is an open-label, single center, pilot trial to evaluate the safety and efficacy of toripalimab and gemcitabine in patients with recurrent or metastatic nasopharyngeal carcinoma.

Study Overview

Study Type

Interventional

Enrollment (Actual)

21

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 Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 51006
        • Ming-Yuan Chen

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. Male or female; 18-70 years of age.
  2. Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment.
  3. did't receive any systemic chemotherapy for recurrent and metastatic lesions.
  4. Intolerance to or rejection of platinum-based chemotherapy
  5. ECOG performance status of 0 or 1.
  6. Life expectancy more than 12 weeks.
  7. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
  8. Adequate organ function assessed by laboratory parameters during the screening period
  9. Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. A highly effective method of contraception is defined as one that results in a low failure rate, that is, less than 1% per year when used consistently and correctly
  10. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
  2. Known history of hypersensitivity to any components of the Toripalimab formulation;
  3. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
  4. Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
  5. Uncontrolled clinically significant medical condition, including but not limited to the following:

    1. congestive heart failure (New York Health Authority Class > 2),
    2. unstable angina,
    3. myocardial infarction within the past 12 months,
    4. clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
  6. Active infection or an unexplained fever; 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
  7. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
  8. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results; Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Toripalimab plus gemcitabin arm
Subjects receive gemcitabine and toripalimab.
Subjects receive gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21 days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) maintenance. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 1 year
The safety will be assessed according to CTCAE (V5.0)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients who achieved an objective response
Time Frame: 1 year
Defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;
1 year
The proportion of patients who achieved disease control
Time Frame: 1 year
Defined as those with RECIST-defined objective response or stable disease according to RECIST 1.1 assessed by the investigator;
1 year
The proportion of patients who achieved clinical benefit
Time Frame: 1 year
Defined as those with confirmed objective response or stable disease that lasted for at least 6 months;
1 year
Progression-free survival
Time Frame: 1 year
Defined from the enrolment to RECIST defined progression or death from any causes;
1 year
Duration of response
Time Frame: 1 year
Defined as the time from first documentation of objective response to radiological disease progression.
1 year

Collaborators and Investigators

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

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)

May 30, 2020

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (ACTUAL)

May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

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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