Brief Title
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
Official Title
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
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
progression-free survival(PFS)
Secondary Outcome
overall survival(OS)
Condition
Metastatic Nasopharyngeal Carcinoma
Intervention
Capecitabine plus toripalimab
Study Arms / Comparison Groups
Capecitabine plus toripalimab maintenance therapy
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 2022
Completion Date
September 2029
Primary Completion Date
September 2027
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
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Yin Wen-Jing, 0086-13929503157, [email protected]
Administrative Informations
NCT ID
NCT05484375
Organization ID
IIT-2022-017(FL5)
Responsible Party
Principal Investigator
Study Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor
Yin Wen-Jing, Study Director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Verification Date
July 2022