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

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT06156332
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors With Neuroendocrine Differentiation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • surufatinib、serplulimab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 28, 2024
Status verified
Nov 2023
Primary completion
Jan 28, 2025
Completion
Jan 28, 2027

Study Design

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

Arms

  • Experimental: surufatinib combined with 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.

Primary Outcome Measure

ORR [ Time Frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Central Contacts