First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06070740
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Neuroendocrine Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab and Chemotherapy(oxaliplatin and capecitabine) — DRUG
    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.

Study Details

First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study \[NCT ID not yet assigned\]

Key Dates

Start date
Nov 1, 2023
Status verified
Oct 2023
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy as first-line treatment
    Durvalumab combined with XELOX chemotherapy as the first-line treatment

Primary Outcome Measure

Objective Response Rate [ Time Frame: through study completion, an average of 1 year ]

Central Contacts