Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Oct 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with advanced gastric neuroendocrine carcinoma, a type of stomach cancer. The study aims to find out if combining two medications, surufatinib and sintilimab, with standard chemotherapy can improve treatment outcomes, such as the effectiveness of the treatment and overall survival time. The researchers are also looking at how safe and tolerable this combination is for patients.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of advanced gastric cancer that has not been treated with systemic therapies before. They should also have measurable cancer lesions and generally good health, as indicated by their physical condition and organ function. Participants will have the opportunity to contribute to important research that could lead to better treatment options for gastric neuroendocrine carcinoma. If you or a loved one meets these criteria and is interested in participating, you would be asked to sign an informed consent form to ensure you understand the study and its potential risks and benefits.

Gender

ALL

Eligibility 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.