NCT06156332

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

A Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-28
• Primary completion: 2025-01-28
• Completion: 2027-01-28
• First posted: 2023-12-05
• Last updated: 2023-12-05