Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma (NCT07156019) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma
32 participantsStarted 2025-10
Plain-language summary
This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months. Efficacy evaluation was performed at the end of every 2 treatment cycles. After termination of study treatment, participants will be followed up for safety and survival (survival follow-up every 90 days).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
. Locally advanced unresectable or metastatic neuroendocrine carcinoma confirmed by histopathology or cytology (excluding small cell lung cancer);
. Disease progression or toxicity intolerance after previous first-line and above treatment;
. At least one measurable lesion according to RECIST v1.1;
. Eastern Cooperative Oncology Group Performance Status（ECOG PS） score is 0-1;
. Age ≥18 and ≤75 years old;
. Can provide tumor specimens for biomarker detection；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: From enrollment to the end of treatment at 1 year
Trial details
NCT IDNCT07156019
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Major organ and bone marrow function levels meet the following requirements within 7 days prior to treatment:
Exclusion criteria
. Previous exposure to any anti-PD-1 /PD-L1/PD-L2/CTLA-4 antibody, VEGF/VEGFR targeting drugs;
. Previous treatment with temozolomide;
. 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;
. Known to be allergic to any monoclonal antibody, temozolomide preparations, and solfantinib preparations;
. 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;
. There was toxicity caused by previous anti-tumor therapy that did not recover to NCI CTCAE5.0 version ≤ Grade 1 before the first administration;
. 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;
. Patients with metastatic central nervous system or cancerous meningitis with clinical symptoms;