CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 62 target
Drug / intervention
Immunotherapy (Sintilimab) +2 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Histologically confirmed colorectal adenocarcinoma with liver metastases
  • MSS/pMMR subtype
  • Previously received standard first- and second-line systemic anti-tumor therapy
  • At least one measurable lesion per RECIST 1.1
Key exclusion· 9
  • Other malignancies within 3 years prior to enrollment
  • Participating in other interventional clinical studies or receiving investigational drugs within past 4 weeks
  • Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or T cell co-stimulatory/co-inhibitory receptor inhibitors
  • Prior fruquintinib

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

Search/NCT06356584
NCT06356584Phase 2RecruitingOn TrackUpdated 2mo ago

Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial

Shandong Cancer Hospital and Institute·interventional·Posted Apr 10, 2024·Updated Apr 28, 2026

In Brief

A Phase 2 clinical trial evaluating Immunotherapy (Sintilimab), Targeted Therapy Agent (Fruquintinib), and 1 other intervention for Colorectal Cancer and 4 related conditions. Currently recruiting, targeting 62 participants across 1 site.

Detailed Summary

Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.

Study Details

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

Timeline

Phase 2Recruiting
20252026
First PostedApr 10, 2024
Enrollment StartApr 1, 2024
Primary CompletionOct 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 2.2 years agoPrimary completion in 3 months

Interventions

Immunotherapy (Sintilimab)drug

Sintilimab

Targeted Therapy Agent (Fruquintinib)drug

Fruquintinib

Radiotherapy (SBRT and LDRT)radiation

SBRT and LDRT