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Trial Title:
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
NCT ID:
NCT05484375
Condition:
Metastatic Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Capecitabine
Conditions: Keywords:
nasopharyngeal carcinoma
capecitabine
toripalimab
maintenance therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine plus toripalimab
Description:
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab:
240mg, intravenous drip, d1, every 3 weeks
Arm group label:
Capecitabine plus toripalimab maintenance therapy
Summary:
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:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histology confirmed metastatic nasopharyngeal carcinoma following radical
treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
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:
1. History of severe anaphylaxis to any component of capecitabine or toripalimab
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
September 2022
Completion date:
September 2029
Lead sponsor:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Source:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484375
