NCT07156019

Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma

A Prospective, Single-center, Single-arm Phase II Study of Sintilimab in Combination With Surufatinib and Temozolomide in the Treatment of Advanced Neuroendocrine Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (body surface area（BSA）≤1.7m2; BSA \>1.7m2 was administered with 300mg, once daily, d1-d5, and with Surufatinib (250mg, once daily, continuous administration). 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. For subjects whose disease progression was evaluated for the first time according to Response Evaluation Criteria in Solid Tumors, version 1.1（RECIST v1.1）, the investigator determined that the subjects were clinically stable and still had clinical benefit, the subjects could continue to receive treatment, and the disease progression was confirmed according to Immune Response Evaluation Criteria in Solid Tumors（iRECIST） criteria 4-6 weeks later. After termination of study treatment, participants will be followed up for safety and survival (survival follow-up every 90 days).

Conditions

• Neuroendocrine Carcinomas (NEC)

Interventions

Type	Name	Description
DRUG	Sintilimab+Temozolomide+Surufatinib	After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (BSA≤1.7m2; BSA \> 1.7m2 was administered with 300mg, QD, d1-d5, and with Surufatinib (250mg, QD, continuous administration). 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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-09-04
• Last updated: 2025-09-04