Triple-Drug cocktail aims to tackle rare cancer
NCT ID NCT07156019
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of three drugs—sintilimab, surufatinib, and temozolomide—in 32 people with advanced neuroendocrine carcinoma that has worsened after prior treatment. The goal is to see if the combination can shrink tumors and control the disease. Participants receive the drugs in 21-day cycles for up to 24 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab, surufatinib, and temozolomide
- What this could lead to
- If successful, this combination could offer a new treatment option to shrink tumors and delay progression in advanced neuroendocrine carcinoma.
- What could go wrong
- This is a small, early-phase study with only 32 participants. The combination may cause significant side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good; 2. Locally advanced unresectable or metastatic neuroendocrine carcinoma confirmed by histopathology or cytology (excluding small cell lung cancer); 3. Disease progression or toxicity intolerance after previous first-line and above treatment; 4. At least one measurable lesion according to RECIST v1.1; 5. Eastern Cooperative Oncology Group Performance Status(ECOG PS) score is 0-1; 6. Age ≥18 and ≤75 years old; 7. Can provide tumor specimens for biomarker detection; 8. Major organ and bone marrow function levels meet the following requirements within 7 days prior to treatment: ① Blood routine: Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥9.0 g/dL; Have not received transfusions of blood products (including erythrocyte and platelet products, etc.) and have not used supportive therapy of growth factors (including colony-stimulating factor, interleukin and erythropoietin, etc.) within 2 weeks before the examination; ② Liver function: serum total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN); alanine Aminotransferase(ALT) and aspartate aminotransferase (AST) in subjects without liver metastasis ≤3.0×ULN, and ALT and AST in subjects with liver metastasis ≤5.0×ULN; ③ Renal function: serum creatinine (Cr) ≤1.5×ULN; ④ Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN; ⑤ Urine routine results showed that urine protein \<2+; For patients with urine protein ≥2+ in routine urine testing at baseline, a 24-hour urine protein quantity of \<1g is required; 9. Expected survival time ≥3 months; 10. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period. Exclusion Criteria: 1. Previous exposure to any anti-PD-1 /PD-L1/PD-L2/CTLA-4 antibody, VEGF/VEGFR targeting drugs; 2. Previous treatment with temozolomide; 3. Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs within 4 weeks prior to enrollment, or remained within 5 half-lives of such drugs; 4. Known to be allergic to any monoclonal antibody, temozolomide preparations, and solfantinib preparations; 5. Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhalation, or other routes of local corticosteroids or physiological doses of systemic corticosteroids; 6. There was toxicity caused by previous anti-tumor therapy that did not recover to NCI CTCAE5.0 version ≤ Grade 1 before the first administration; 7. History of other primary malignancies, except the following: non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence, carcinoma in situ with adequate treatment and no evidence of disease recurrence; 8. Patients with metastatic central nervous system or cancerous meningitis with clinical symptoms; 9. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis; 10. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 11. Have serious heart disease or discomfort; 12. The patient has any active autoimmune disease or a history of autoimmune disease within 2 years; 13. Pregnant or nursing female patients; 14. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 15. Had undergone major surgery within 4 weeks prior to enrollment or expected to require major surgery during the study treatment; 16. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 17. Has a serious concomitant disease or other comorbidities that interfere with planned treatment; 18. Any other circumstances deemed inappropriate for participation in this study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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