Actively Recruiting
Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)
Led by Peking University · Updated on 2025-03-14
30
Participants Needed
2
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent before any study procedure
- Aged 18 to 75 years (inclusive)
- Histologically or cytologically confirmed inoperable or metastatic high-grade neuroendocrine neoplasm (Ki67 index > 20% or mitotic count > 20 per high power field)
- Failed, intolerant, unsuitable for, refused, or have no standard treatment options
- Have clear measurable lesions according to RECIST 1.1 or evidence of progression if previously locally treated
- Agree to provide tumor specimens for further diagnosis and analysis
- ECOG performance status 0 or 1
- Asymptomatic or stable brain metastases after local treatment with no recent symptoms or glucocorticoid use
- Completed palliative radiation therapy at least 14 days prior with toxicity resolved to grade 1 or less
- Predicted survival of 3 months or more
- Adequate organ function based on specified laboratory tests within 7 to 14 days before first dose
- Negative pregnancy test for females of childbearing potential within 3 days before first dose
- Agree to use effective contraception during study and for 120 days after last dose if at risk of conception
You will not qualify if you...
- Other malignancies within past 5 years except controlled basal or squamous cell skin cancer and cervical carcinoma in situ
- Participation in another interventional study or treatment with investigational drug/device within 4 weeks prior
- Prior use of PD-1, PD-L1, PD-L2, CTLA-4 antibodies or other immune checkpoint therapies, or anti-VEGF/VEGFR drugs
- Abnormal thyroid function with symptoms or requiring treatment, except controlled hypothyroidism
- Recent systemic therapy with anti-neuroendocrine tumor proprietary Chinese medicines or immunomodulators within 2 weeks
- Active autoimmune disorders needing systemic treatment or history of autoimmune disease within 2 years
- Immunosuppressant use within 7 days prior, except local or physiological glucocorticoids
- Uncontrollable malignant effusions requiring drainage
- Use of CYP3A inducers during or shortly before study
- Active gastric or duodenal ulcers, ulcerative colitis, bleeding tumors, or serious gastrointestinal conditions
- Recent significant bleeding events within 2 months or hemoptysis within 4 weeks
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of severe allergy to study drugs or similar compounds
- Conditions affecting oral medication intake
- Unresolved toxicity from prior treatment above grade 1 except hair loss
- HIV positive
- Untreated active hepatitis B or uncontrolled hepatitis C infection
- Live or attenuated vaccine within 4 weeks prior or during study
- Pregnant or lactating women
- Serious uncontrolled systemic illness or conditions that increase risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Bejing cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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