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New treatment option for Neuroendocrine Neoplasm
Official title Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)
ClinicalTrials.gov ID: NCT05165407
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for neuroendocrine neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients who included in this study must fulfil all of the following criteria:
- Fully aware of this study and voluntary to sign the informed consent form (the informed consent form must be signed before any trial-specific...
- Aged 18-75 (inclusive);
- Histologically or cytologically confirmed patients with inoperable or metastatic high-grade neuroendocrine neoplasm (Ki67 index \> 20% or with...
- Patients who failed to receive standard treatment (Have progressed on previous treatment, or treatment toxicity and side effects are not tolerated)...
You likely can't join if
- people must be excluded from this study when any one of the following criteria is met:
- Presence of other malignancies in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of...
- Currently participate in an treatment clinical study, or have been treated with another study drug or medical equipment within 4 weeks prior to the...
- Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways...
- Having abnormal thyroid function with symptoms ongoing or requiring treatment at screening (only hypothyroidism that can be controlled by thyroid...
- Received systemic therapy with anti-neuroendocrine tumor of proprietary Chinese medicines or immunomodulatory drugs (including thymosin, interferon...
See the full eligibility criteria
Who can join
- Patients who included in this study must fulfil all of the following criteria:
- Fully aware of this study and voluntary to sign the informed consent form (the informed consent form must be signed before any trial-specific procedure is performed);
- Aged 18-75 (inclusive);
- Histologically or cytologically confirmed patients with inoperable or metastatic high-grade neuroendocrine neoplasm (Ki67 index \> 20% or with mitotic count of more than 20 mitoses per high power field);
- Patients who failed to receive standard treatment (Have progressed on previous treatment, or treatment toxicity and side effects are not tolerated), or cannot receive standard treatment (including patients who are...
- Having clear measurable lesions (according to RECIST 1.1). If the lesion is the only one that has received previous local treatment (radiotherapy, ablation, vascular intervention, etc.), there must be clear imaging...
- Agree to provide tumor specimens (for further diagnosis of pathological grade, detection of PD-L1 expression and lymphocyte infiltration);
- ECOG performance status of 0 or 1;
- Brain metastases are asymptomatic or stable after local treatment are allowed to be enrolled as long as they meet the following conditions: 1) Measurable lesions are outside of the central nervous system 2) No central...
- Absolute neutrophil count (ANC) ≥1.5x109/L within 14 days, without use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor.
- Platelet count ≥100×109/L within 14 days, without blood transfusion or use of blood product.
- Hemoglobin ≥ 9 g/dL within 14 days, without blood transfusion or erythropoietin.
- Total bilirubin ≤1.5 × upper limit of normal (ULN); Such as total bilirubin \> 1.5×ULN, but direct bilirubin ≤ ULN was also allowed.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis).
- Serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL /min (calculated according to the Cockcroft-Gault formula).
- Good coagulation function, defined as International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN;
- Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, people with total T3 (or FT3) and FT4 within the normal range can be...
- The myocardial enzyme profile is within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not clinically significant, the patients is allowed to be enrolled); 12...
What rules you out
- people must be excluded from this study when any one of the following criteria is met:
- Presence of other malignancies in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix, which were effectively controlled);
- Currently participate in an treatment clinical study, or have been treated with another study drug or medical equipment within 4 weeks prior to the first dose;
- Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.)...
- Having abnormal thyroid function with symptoms ongoing or requiring treatment at screening (only hypothyroidism that can be controlled by thyroid hormone replacement therapy can be included);
- Received systemic therapy with anti-neuroendocrine tumor of proprietary Chinese medicines or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local control of pleural effusion) within 2...
- Patients with any active autoimmune disorders requiring systematic treatment (e.g., palliative drugs, glucocorticoids, or immunosuppressants) or a history of autoimmune disease in the past 2 years. Alternative therapies...
- Use of immunosuppressant within 7 days prior to the first dose, not including local glucocorticoid via nasal spray, inhalation or other routes or systemic glucocorticoid at physiological dose. Note: Physiological doses...
- Uncontrollable malignant hydrothorax, ascites or pericardial effusion (patients who do not need drainage effusion or who stop drainage for 3 days without significant increase in effusion can be included in the group);
- Use of CYP3A potent or moderate inducers during the administration of concomitant medications or within 1 weeks or 5 half-lives (whichever is longer) prior to the first dose (Appendix 3);
- Patients who currently have gastric and duodenal active ulcer, ulcerative colitis, or active bleeding in the unresected tumor, or serious gastrointestinal disorders, or other conditions that may cause haemorrhage of...
- Patients with evidence or history of obvious bleeding tendency within 2 months prior to the first dose. (bleeding within 2 months \> 30 mL, hematemesis, black feces), hemoptysis (within 4 weeks \> 5 mL of fresh blood);
- Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs (Sintilimab, IBI310, Surufatinib), or a prior history of severe allergy to any other monoclonal...
- Patients with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss);
- Human immunodeficiency virus (HIV) antibody positive;
- Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of the normal value in the laboratory department of the research center); Note: Hepatitis B people who meet...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.