Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
NCT ID: NCT05484375
Last Updated: 2022-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-09-30
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Capecitabine plus toripalimab 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.
Capecitabine plus toripalimab
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks
Interventions
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Capecitabine plus toripalimab
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
3. Age ≥18 years and ≤65 years
4. WBC≥4×10\^9/L, platelet ≥ 100×10\^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
5. With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
6. With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
7. ECOG score is 0-1
8. At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
9. Life expectancy is at least 12 weeks
10. Patients sign informed consent forms
Exclusion Criteria
2. Active or untreated central nervous system metastases
3. Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
4. Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
5. Patients with poorly controlled or symptomatic hypercalcemia
6. Pregnancy or lactation
7. 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.
8. Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
9. History of autoimmune diseases
10. 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.
11. Receive any active vaccine within 4 weeks prior to enrollment
12. Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
13. Active pneumonia
14. Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
15. Presence of severe neurological or psychiatric disorders, including dementia and seizures.
16. Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
17. Major cardiovascular diseases
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Hunan Cancer Hospital
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Wenjing Yin
attending physician
Principal Investigators
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Yin Wen-Jing
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Central Contacts
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Other Identifiers
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IIT-2022-017(FL5)
Identifier Type: -
Identifier Source: org_study_id
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