Toripalimab and Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma.

Study Overview
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Brief Summary
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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.

Official Title
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Toripalimab Combined With Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma

Conditions
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Chemotherapy Effect, Immunotherapy, Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Toripalimab plus gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; 18-70 years of age. Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment. did't receive any systemic chemotherapy for recurrent and metastatic lesions. Intolerance to or rejection of platinum-based chemotherapy ECOG performance status of 0 or 1. Life expectancy more than 12 weeks. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1. Adequate organ function assessed by laboratory parameters during the screening period 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 Able to understand and sign an informed consent form (ICF). Exclusion Criteria: 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; Known history of hypersensitivity to any components of the Toripalimab formulation; 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; Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease); Uncontrolled clinically significant medical condition, including but not limited to the following: congestive heart failure (New York Health Authority Class &gt; 2), unstable angina, myocardial infarction within the past 12 months, clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; 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); History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toripalimab plus gemcitabin arm<br>Subjects receive gemcitabine and toripalimab. | Drug: Toripalimab plus gemcitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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 | 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 | 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 | Defined as those with confirmed objective response or stable disease that lasted for at least 6 months; | 1 year | 
| Progression-free survival | Defined from the enrolment to RECIST defined progression or death from any causes; | 1 year | 
| Duration of response | Defined as the time from first documentation of objective response to radiological disease progression. | 1 year |