First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study \[NCT ID not yet assigned\]
A prospective Single-arm Phase II Study to evaluate the effectiveness and safety of the combination treatment of durvalumab with XELOX chemotherapy as the first-line in advanced gastrointestinal neuroendocrine carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Combination therapy includes: Durvalumab: intravenous infusion with a fixed dose of 1500 mg on day 1, repeated every 3 weeks ± 3 days; Chemotherapy: Oxaliplatin 130mg/m2 intravenous infusion on day 1, capecitabine 1000mg/m2, orally, twice a day, from day 1 to day 14; repeated every 3 weeks ± 3 days; After 6 cycles of combination therapy, maintain with durvalumab 1500 mg every 4 weeks ± 3 days for 2 years. Terminate the trial if confirmed disease progression, initiation of other anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent or other reasons considered by the investigators.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate
The proportion of patients who achieved complete remission or partial remission due to tumor size reduction (according to RECIST 1.1 standard)
Time frame: through study completion, an average of 1 year
Disease Control Rate
The proportion of patients whose tumor shrinks and achieve complete remission, partial remission or stable condition (according to RECIST 1.1 standard);
Time frame: through study completion, an average of 1 year
Progression-free Survival
from the time of enrollment to the time of progression or death from any cause;
Time frame: through study completion, an average of 1 year
Overall survival time
from the time of enrollment to the time of death;
Time frame: through study completion, an average of 1 year
Adverse events
the frequency and severity of all adverse events (Adverse Event, AE), the severity of adverse events is evaluated according to the CTC AE v5.0 standard
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.