Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2024
CompletedFirst Posted
Study publicly available on registry
July 31, 2024
CompletedStudy Start
First participant enrolled
August 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 9, 2027
July 31, 2024
July 1, 2024
3 years
July 28, 2024
July 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
time from first-dose to the first documented disease progression or death
approximately 1 years
Secondary Outcomes (2)
Objective response rate (ORR)
approximately 1 years
Disease Control Rate (DCR)
approximately 1 years
Study Arms (1)
Surufatinib + serplulimab + standard chemotherapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));
- Have at least one measurable lesion according to RECIST v1.1;
- ECOG performance status: 0-1;
- No previous systemic therapy;
- Urine protein\< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
- Expected survival time \> 3 months;
You may not qualify if:
- Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;
- With active bleeding or bleeding tendency;
- Severe history of cardiovascular and cerebrovascular diseases;
- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji hospital
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liwei Wang, Doctorate
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of department of oncology
Study Record Dates
First Submitted
July 28, 2024
First Posted
July 31, 2024
Study Start
August 10, 2024
Primary Completion (Estimated)
August 9, 2027
Study Completion (Estimated)
August 9, 2027
Last Updated
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share