CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 30 target
Drug / intervention
Sintilimab +2 moredrug
Likely dose
Sintilimab 200mgfrom record
Key inclusion· 9
  • ✓Histologically or cytologically confirmed inoperable or metastatic high-grade neuroendocrine neoplasm
  • ✓Ki67 index >20% or mitotic count >20 mitoses per high power field
  • ✓Failed standard treatment or cannot receive standard treatment
  • ✓Clear measurable lesions per RECIST 1.1
Key exclusion· 21
  • ✕Other malignancy within past 5 years (except skin or cervical carcinoma in situ)
  • ✕Currently in or treated with another investigational drug within 4 weeks
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-VEGF/VEGFR therapy
  • ✕Abnormal thyroid function with ongoing symptoms or requiring treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05165407
NCT05165407Phase 2RecruitingUpdate OverdueUpdated 15mo ago · Completion was 9mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Peking University·interventional·Posted Dec 21, 2021·Updated Mar 14, 2025

In Brief

A Phase 2 clinical trial evaluating Sintilimab, IBI310, and 1 other intervention for Neuroendocrine Neoplasm. Currently recruiting, targeting 30 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Neoplasm
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20222023202420252026
First PostedDec 21, 2021
Enrollment StartJul 12, 2022
Primary CompletionSep 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 4.5 years ago

Interventions

Sintilimabdrug

Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

IBI310drug

IBI310 1mg/kg be intravenously administered on Day 1 of every 2 cycle

Surufatinibdrug

Surufatinib 250mg will be taken orally once daily continuously