CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 24 target
Drug / intervention
Anlotinib Plus Toripalimabdrug
Likely dose
Anlotinib Plus Toripalimab 12mgfrom record
Key inclusion· 7
  • ✓Histologically confirmed UICC stage IV gastric cancer
  • ✓No prior systemic anti-cancer treatment, or relapse/metastases >12 months after adjuvant chemotherapy
  • ✓At least one measurable lesion
  • ✓Radiotherapy allowed if completed ≥3 weeks before recruitment and lesion not used for RECIST assessment
Key exclusion· 11
  • ✕HER2 positive (IHC 3+ or IHC 2+ with FISH positive)
  • ✕dMMR/MSI-H status
  • ✕Myocardial infarction, unstable angina, or Grade III-IV heart failure (NYHA)
  • ✕Prior anlotinib or other immune checkpoint inhibitor

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

Search/NCT04278222
NCT04278222Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 20mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial

Shanghai Changzheng Hospital·interventional·Posted Feb 20, 2020·Updated Jul 10, 2024

In Brief

A Phase 2 clinical trial evaluating Anlotinib Plus Toripalimab for Gastric Cancer and 3 related conditions. Currently recruiting, targeting 24 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Immunotherapy, Anlotinib, Toripalimab
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
2020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartFeb 10, 2020
Primary CompletionOct 31, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.4 years ago

Interventions

Anlotinib Plus Toripalimabdrug

Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w