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A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.

NCT05747729 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-28

No results posted yet for this study

Summary

This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. This clinical trial evaluates the efficacy and safety of surufatinib and serplulimab combined with standard chemotherapy (Platinum/Etoposide) in neuroendocrine carcinoma.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

Surufatinib and Serplulimab

Surufatinib: Safety lead-in : Oral, QD, starting dose 250 mg, adjusted according to DLT. Dose expansion: administration according to the dose determined in the safety lead-in phase. Serplulimab: 300 mg intravenous infusion on day 1, repeated every 3 weeks.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-02-28
Completion
2026-02-28

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 NCT05747729 on ClinicalTrials.gov