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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab plus gemcitabin arm | Experimental | Subjects receive gemcitabine and toripalimab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab plus gemcitabine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The safety will be assessed according to CTCAE (V5.0) | 1 year |
| 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 |
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Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ming-Yuan Chen | Guangzhou | Guangdong | 51006 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
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 |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |