NCT06531291Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 80 (estimated)
First submitted: 28 Jul 2024
Start date: 10 Aug 2024
Primary completion date: 9 Aug 2027
Lead sponsor: RenJi Hospital
Diseases: Pancreatic cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
NCT number: NCT06531291

What you commit to

Study type: Interventional · Phase 2
Planned participants: 80
From 10 Aug 2024 to the primary completion date, 9 Aug 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Other illness

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;

Who the study is looking for

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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
RenJi Hospital Coordinator of this site? Confirm its status	Shanghai	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.