CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 102 target
Drug / intervention
gemcitabine and oxaliplatin. +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Chinese ethnicity
  • ✓ECOG performance status 0-1
  • ✓Resectable gallbladder carcinoma confirmed by histopathology or cytopathology after radical surgery
  • ✓Adequate fresh tumor tissue available for genome sequencing and immunohistochemistry
Key exclusion· 14
  • ✕Prior anti-tumor molecular targeted therapy
  • ✕Anti-tumor chemotherapy within 6 months
  • ✕Prior lesions treated by irradiation
  • ✕Participation in other therapeutic or interventional clinical trials

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

Search/NCT04183712
NCT04183712Phase 2RecruitingUpdate OverdueUpdated 20mo ago · Completion was 13mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.

Shanghai Jiao Tong University School of Medicine·interventional·Posted Dec 3, 2019·Updated Oct 16, 2024

In Brief

A Phase 2 clinical trial evaluating gemcitabine and oxaliplatin. and Afatinib for Gallbladder Carcinoma. Currently recruiting, targeting 102 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGallbladder Carcinoma
CountriesChina
CollaboratorsShanghai Zhongshan Hospital, Ruijin Hospital, RenJi Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Anhui Medical University, Shanghai East Hospital of Tongji University, Changshu Affiliated Hospital of Soochow University, Qinghai People's Hospital, The Second People's Hospital of Baoshan, Yunnan Province, Lanzhou University Second Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First People's Hospital of Nantong

Timeline

Phase 2RecruitingOverdue
2020202120222023202420252026
First PostedDec 3, 2019
Enrollment StartJun 1, 2020
Primary CompletionJun 1, 2025
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 6.6 years ago

Interventions

gemcitabine and oxaliplatin.drug

GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

Afatinibdrug

Target therapy Drug: afatinib