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 range18 Years – 75 Years
SexALL
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；
✓. 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;
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
✕. 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;