Clinical trial NCT06531291: Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: ESCC
Biliary Tract Cancer
Gastric Cancer
Pancreas Cancer
Keywords: surufatinib
Neuroendocrine Differentiation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: approximately 1 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: approximately 1 years
measure: Disease Control Rate (DCR)
timeFrame: approximately 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Liwei Wang, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: