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

NCT06070740 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-10-06

No results posted yet for this study

Summary

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

Conditions

  • Gastrointestinal Neuroendocrine Carcinoma

Interventions

DRUG

Durvalumab and Chemotherapy(oxaliplatin and capecitabine)

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yuejuan Cheng · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070740 on ClinicalTrials.gov