NCT06531291

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Detailed description

This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Conditions

• ESCC
• Biliary Tract Cancer
• Gastric Cancer
• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	250 mg, po, qd, q3w
DRUG	Serplulimab	200 mg, iv, d1, q3w
DRUG	standard chemotherapy	Decided by PI

Timeline

• Start date: 2024-08-10
• Primary completion: 2027-08-09
• Completion: 2027-08-09
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

1 site across 1 country: China