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Trial Title:
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation
NCT ID:
NCT06531291
Condition:
ESCC
Biliary Tract Cancer
Gastric Cancer
Pancreas Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Pancreatic Neoplasms
Conditions: Keywords:
surufatinib
Neuroendocrine Differentiation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
250 mg, po, qd, q3w
Arm group label:
Surufatinib + serplulimab + standard chemotherapy
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
200 mg, iv, d1, q3w
Arm group label:
Surufatinib + serplulimab + standard chemotherapy
Intervention type:
Drug
Intervention name:
standard chemotherapy
Description:
Decided by PI
Arm group label:
Surufatinib + serplulimab + standard chemotherapy
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.
Criteria for 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 > 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Contact:
Last name:
Liwei Wang, Dr
Phone:
+86 16621086648
Email:
lwwang2013@163.com
Start date:
August 10, 2024
Completion date:
August 9, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06531291
