Combining Surufatinib and Sintilimab with Chemotherapy for Advanced Gastric Neuroendocrine Carcinoma

A Single-center, Open Phase II Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma

This study is testing if combining two new medications with standard chemotherapy can help people with advanced gastric neuroendocrine carcinoma live longer and feel better.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, sintilimab, surufatinib, sindellizumab, solantinib
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06102746 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining surufatinib, an anti-angiogenic therapy, and sintilimab, a PD-1 inhibitor, with a standard chemotherapy regimen for patients with advanced gastric neuroendocrine carcinoma. Patients who have not previously received systemic treatment will undergo a treatment protocol that includes intravenous and oral medications over a year. The study aims to assess the treatment's efficacy in improving survival rates and its safety profile through regular monitoring and imaging assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic gastric neuroendocrine carcinoma who have not received prior systemic anti-tumor therapy.

Not a fit: Patients with prior systemic treatment for gastric neuroendocrine carcinoma or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced gastric neuroendocrine carcinoma.

How similar studies have performed: While this approach combines established therapies, the specific combination of surufatinib and sintilimab in this context is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Ting Deng, MD — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Ting Deng, MD

Conditions Gastric Neuroendocrine Carcinoma; gastric neuroendocrine carcinoma; Sintilimab; Surufatinib