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A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy

NCT06156332 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-12-05

No results posted yet for this study

Summary

Enrolled patients with advanced solid tumors with neuroendocrine differentiation who had failed standard therapy (including those with initial advanced solid tumors with neuroendocrine differentiation and those with newly developed neuroendocrine differentiation after treatment failure) received the combination of serplulimab and surufatinib and continued to be administered until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. A total of 39 patients were enrolled.

Conditions

  • Advanced Solid Tumors With Neuroendocrine Differentiation

Interventions

DRUG

surufatinib、serplulimab

surufatinib: 250 mg (5 capsules) once a day, Q3W, continued until the patient developed disease progression or met other protocol criteria for discontinuation of study treatment; If the patient vomits after taking the medicine, there is no need to take the supplement; The missed dose should not be added the next day, and the next prescribed dose should be taken as usual. serplulimab: 300mg fixed dose, intravenous infusion, d1, Q3W; Continued administration until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. Imaging was used every 6 weeks (±7 days) to evaluate tumor status until disease progression (RECIST 1.1) or death (during patient treatment), and tumor treatment and survival status after disease progression were recorded. The changes of neuroendocrine tumor markers were detected after treatment.

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Yuan-Sheng Zang · Shanghai Changzheng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-28
Primary Completion
2025-01-28
Completion
2027-01-28

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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 NCT06156332 on ClinicalTrials.gov