Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

Study Overview
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Brief Summary
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to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.

Detailed Description
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This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.

Official Title
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Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study

Conditions
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Metastatic Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Capecitabine plus toripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1） Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies Age ≥18 years and ≤65 years WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln) With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min) ECOG score is 0-1 At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab) Life expectancy is at least 12 weeks Patients sign informed consent forms Exclusion Criteria: History of severe anaphylaxis to any component of capecitabine or toripalimab Active or untreated central nervous system metastases Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate. Patients with poorly controlled or symptomatic hypercalcemia Pregnancy or lactation Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment. Patients who have previously received allogeneic bone marrow transplants or solid organ transplants. History of autoimmune diseases Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug. Receive any active vaccine within 4 weeks prior to enrollment Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study Active pneumonia Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV. Presence of severe neurological or psychiatric disorders, including dementia and seizures. Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE Major cardiovascular diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Capecitabine plus toripalimab maintenance therapy<br>capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached. | Drug: Capecitabine plus toripalimab<br>* Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) | The time is defined from the enrolment to progression or death from any cause | up to 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) | The time is defined from the enrolment to death from any cause | up to 24 month | 
| Objective Response Rate(ORR) | The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1 | up to 24 month | 
| Disease Control Rate (DCR) | The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1 | up to 24 month | 
| Duration of Response (DoR) | The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator | up to 24 month | 
| Adverse Events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0 | up to 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maintenance therapy, nasopharyngeal carcinoma, capecitabine, toripalimab