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Trial Title:
A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.
NCT ID:
NCT05747729
Condition:
Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Neuroendocrine
Study type:
Interventional
Study phase:
Phase 1/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 and Serplulimab
Description:
Surufatinib: Safety lead-in : Oral, QD, starting dose 250 mg, adjusted according to DLT.
Dose expansion: administration according to the dose determined in the safety lead-in
phase.
Serplulimab: 300 mg intravenous infusion on day 1, repeated every 3 weeks.
Arm group label:
Surufatinib/Serplulimab/Platinum/Etoposide
Summary:
This study is a prospective open-label, single-arm, single-center clinical study.
Patients with neuroendocrine carcinoma who had not previously received standard therapy
were enrolled in this study once they have signed the informed consent form (ICF) and
been identified as eligible in screening. This clinical trial evaluates the efficacy and
safety of surufatinib and serplulimab combined with standard chemotherapy
(Platinum/Etoposide) in neuroendocrine carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent;
2. With histologically or cytologically confirmed extra-pulmonary neuroendocrine
carcinoma (including mixed neuroendocrine or non-neuroendocrine tumors [at least 30%
neuroendocrine carcinoma component]);
3. Previously untreated with systemic therapy;
4. age ≥18 years;
5. Have at least one measurable lesion according to RECIST v1.1;
6. ECOG performance status: 0-1;
7. Expected survival time > 3 months;
8. For evidence of sufficient organ functions, the subjects shall meet the following
laboratory parameters: 1) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without use
of granulocyte colony stimulating factor in recent 14 days; 2) Platelet count ≥ 100
× 109/L without blood transfusion in recent 14 days; 3) Hemoglobin > 9 g/dL without
blood transfusion or erythropoietin use in recent 14 days; 4) Total bilirubin ≤ 1.5
× upper limit of normal (ULN); or total bilirubin > ULN, direct bilirubin ≤ ULN; 5)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (ALT
or AST ≤ 5 × ULN for patients with liver metastasis); 6) Blood creatinine ≤ 1.5 ×
ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥ 50 mL/min;
9. Women of childbearing potential need to use at least one medically approved
contraceptive measure (such as intrauterine device, contraceptive pill or condom)
during the study treatment and within 180 days after the end of the study treatment;
Before the first dose, serum HCG examination must be negative; and women must be
non-lactating.
Exclusion Criteria:
1. Neuroendocrine carcinoma of the lung;
2. With known allergic reactions to the drugs in this study;
3. Unable or unwilling to swallow Surufatinib or suffering from significant digestive
system diseases that may interfere with absorption, metabolism, or excretion;
4. With clinically significant or uncontrolled heart diseases, including unstable
angina, acute myocardial infarction within 6 months before the first dose, grade
III/IV congestive heart failure (New York Heart Association), and uncontrolled
arrhythmia (subjects with pacemakers or with atrial fibrillation but well controlled
heart rate are allowed); With ECG changes or medical history considered clinically
significant by the investigator; QTc interval > 450 ms for male or > 470 ms for
female at screening;
5. With active ulcers, intestinal perforation, and intestinal obstruction;
6. With active bleeding or bleeding tendency;
7. With uncontrolled hypertension (systolic pressure > 150 mmHg or diastolic pressure >
100 mmHg) after the optimal medical treatment;
8. Urine protein ≥ ++ and the amount of urine protein in 24 hours >1.0g;
9. Any active autoimmune disease requiring systemic treatment or with a history of
autoimmune disease within 2 years, including but not limited to interstitial
pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis,
systemic lupus erythematosus, etc. (Vitiligo, psoriasis, alopecia or Grave's disease
without systemic treatment within the past 2 years, and type I diabetic patients who
only need insulin replacement therapy can be included); with a history of primary
immunodeficiency; patients only with positive autoimmune antibody need to confirm
according to the investigator;
10. Received systemic immunostimulant therapy within 4 weeks before the first dose;
11. Received any live vaccines or live attenuated vaccines within 4 weeks prior to the
first dose or planned to be administered live vaccines or live attenuated vaccines
during the study;
12. Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms
that require drainage;
13. Diagnosed with malignant tumors within 5 years before the first dose, excluding
radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma,
and/or radically resected carcinoma in situ;
14. Presence of severe infection in the active phase or with poor clinical control;
1. With known history of human immunodeficiency virus (HIV) infection or confirmed
with positive immune test results;
2. Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA
> 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; or
other hepatitis, liver cirrhosis.
15. Symptomatic brain metastases (confirmed or suspected)
16. The investigator confirms that the patients has any clinical or laboratory
abnormalities who are not suitable for participating in this clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Contact:
Last name:
Tao Zhang, MD
Phone:
027-85871982
Email:
1277577866@qq.com
Start date:
February 28, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747729
