Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| ESCC | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serplulimab | Drug | Serplulimab | ALIAS |
| standard chemotherapy | Drug | Chemotherapy | ALIAS |
| Surufatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surufatinib + serplulimab + standard chemotherapy
- interventionNames
- Drug: Surufatinib
- Drug: Serplulimab
- Drug: standard chemotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- approximately 1 years
- description
- time from first-dose to the first documented disease progression or death
Secondary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- approximately 1 years
- description
- the proportion of patients with complete response or partial response, using RESIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 \> 3 months; Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available