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Clinical Trials in China / NCT06531291
Starting soon Phase 2

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

NCT06531291 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Phase 2
Started
2024-08-10
Last updated
2024-07-31

Condition(s) studied

ESCCBiliary Tract CancerGastric CancerPancreas Cancer

Investigational drug(s) / intervention(s)

Surufatinib →Serplulimab →standard chemotherapy

Surufatinib: 250 mg, po, qd, q3w

Serplulimab: 200 mg, iv, d1, q3w

standard chemotherapy: Decided by PI

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 \&gt; 3 months; Exclusion Criteria: * Have uncontrolled hypertension, defined as systolic blood pressure \&gt;150 mmHg or diastolic blood pressure \&gt;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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Renji hospital Shanghai Shanghai Municipality

More RenJi Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06531291 on ClinicalTrials.gov ↗ ← All trials in China