Spots Global Cancer Trial Database for Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC
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Trial Identification
Brief Title: Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC
Official Title: Sintilimab Combined With IBI310 and Surufatinib for the Treatment of High-grade Advanced-neuroendocrine Neoplasms: a Single Arm, Open-label, Multi Center, Phase II Study
Study ID: NCT05165407
Conditions
Study Description
Brief Summary: 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
Detailed Description: The study population is about 40 patients with high-grade advanced-neuroendocrine neoplasm, who fails or cannot tolerate standard therapies. Surufatinib 250 mg once a day (QD) will be orally administrated, Sintilimab 200mg will be intravenously administered every 3 weeks and IBI310 1mg/kg will be intravenously administered every 6 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Sintilimab, the upper time limit for treatment is 2 years. The primary objective is objective response rate (ORR) of Sintilimab combined with IBI310 and Surufatinib in patients with advanced high-grade advanced-neuroendocrine neoplasm.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Bejing cancer hospital, Beijing, Beijing, China
Contact Details
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