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Trial Title:
Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma
NCT ID:
NCT06102746
Condition:
Gastric Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Neuroendocrine
Conditions: Keywords:
gastric neuroendocrine carcinoma
Sintilimab
Surufatinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab，Surufatinib
Description:
Based on the standard EP regimen, the combination of surufatinib (anti-angiogenic
therapy) and sintilimab (PD-1 inhibitor) were used among patients with advanced gastric
neuroendocrine carcinoma.
Arm group label:
Sintilimab + Surufatinib + EP
Summary:
This study aims to explore whether the combination of surufatinib (anti-angiogenic
therapy) and sintilimab (PD-1 inhibitor) on the basis of EP regimen can further improve
the effective rate and survival time of first-line treatment for patients with advanced
gastric neuroendocrine carcinoma, and explore the safety and tolerability of this
regimen.
Detailed description:
In this study, patients with advanced gastric neuroendocrine carcinoma were selected as
the research object. Based on the standard EP regimen, the combination of surufatinib
(anti-angiogenic therapy) and sintilimab (PD-1 inhibitor) could further improve the
effective rate and survival time of patients, and explore the safety and tolerability of
this treatment regimen.
Patients with advanced gastric neuroendocrine carcinoma who have not received systematic
treatment will be treated with the following protocols:
Sintilimab: 200mg intravenously administered on day 1; Surufatinib: 200mg/ day orally,
taken continuously; Etoposide: 1, 2, 3 days of continuous administration, 100mg/m2,
intravenous infusion; Cisplatin: 75mg/m2 on day 1, or 25mg/m2 on day 1, 2, and 3,
intravenous infusion; One treatment cycle every 21 days; Etoposide and cisplatin were
used for a maximum of 4 cycles, after which maintenance therapy of solantinib and
sindellizumab was administered, and the longest treatment cycle was 13 cycles (a total of
1 year). Patients received regular and periodic reviews, and imaging assessments were
performed every 6 weeks after enrollment in the study. Safety will be evaluated by AE and
laboratory tests. After disease progression, all patients were followed up with their
secondary survival status every 3 months until death.
Criteria for eligibility:
Study pop:
First-line treatment for advanced gastric neuroendocrine carcinoma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
To be enrolled in this trial, patients must meet all of the following inclusion criteria:
1. Locally advanced or metastatic gastric neuroendocrine carcinoma (NEC),
hyperproliferative neuroendocrine tumor (NET G3) or mixed
neuroendocrino-non-neuroendocrine tumor (MiNEN), as demonstrated by pathology (WHO
classification criteria 2019), may also be included;
2. Have not received systematic anti-tumor therapy before;
3. Have received radical treatment in the past and have no treatment interval from the
end of chemotherapy, radiotherapy, or chemoradiotherapy to relapse for at least 6
months (the end time of the last chemotherapy cycle/the end time of the last
radiotherapy);
4. There are measurable lesions defined by the RECIST 1.1 standard;
5. At least 18 years old;
6. ECOG physical condition: 0-1 score;
7. Expected survival of more than 3 months;
8. If the major organs function normally, the following criteria are met:
1. Blood routine examination: hemoglobin (Hb) ≥90g/L; Absolute neutrophil count
(ANC) ≥1.5×10^9/L; Platelet (PLT) ≥100×10^9/L; White blood cell count (WBC)
≥3.0×10^9/L;
2. Biochemical examination: alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤2.5×ULN (tumor liver metastasis, ≤5×ULN); Serum total
bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome subjects, ≤3×ULN); Serum creatinine
(Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min;
3. Coagulation function: activated partial thromboplastin time (APTT),
International Standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
9. The subjects voluntarily joined the study, signed the informed consent, and the
compliance was good.
Exclusion Criteria:
Patients with any of the following conditions were excluded from the study:
1. The presence of a serious illness or medical condition, including but not limited to
the following:
1. Known recurrence in situ or metastasis at any other site;
2. systemic active infection (i.e. infection resulting in body temperature ≥38 °
C);
3. Clinically significant intestinal obstruction, pulmonary fibrosis, renal
failure, liver failure, or symptomatic cerebrovascular disease;
4. Severe/unstable angina, New York Heart Association (NYHA) Class III or IV
symptomatic congestive heart failure;
5. Clinically significant gastrointestinal bleeding;
6. Known presence of human immunodeficiency virus (HIV) or acquired conventional
immunodeficiency syndrome (AIDS) - associated disease, or active hepatitis B or
C;
2. Pregnant or lactating women;
3. The researcher considers it inappropriate to enter this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Deng, MD
Phone:
022-23340123-1051
Email:
xymcdengting@126.com
Start date:
April 10, 2023
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102746
