CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 200 target
Drug / intervention
Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapydrug
Likely dose
Not stated in record
Key inclusion· 6
  • Cytohistological confirmation required for cancer diagnosis
  • Age above 18 years with estimated survival over 3 months
  • Child-Pugh class A or B with ECOG score <2
  • Tolerable coagulation function or reversible coagulation disorders
Key exclusion· 11
  • Participation in clinical trials within 4 weeks
  • Ascites, hepatic encephalopathy, or esophageal and gastric varices bleeding
  • Serious accompanying diseases affecting prognosis (heart disease, uncontrolled diabetes, psychiatric disorders)
  • Other malignancies or past medical history of malignancy

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

Search/NCT03755739
NCT03755739Phase 3RecruitingOn TrackUpdated 24mo ago
Long Recruiting

A Phase II/III Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Nov 28, 2018·Updated Jun 25, 2024

In Brief

A Phase 3 clinical trial evaluating Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy for Hepatocarcinoma and 9 related conditions. Currently recruiting, targeting 200 participants across 1 site.

Detailed Summary

This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.

Study Details

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

Timeline

Phase 3Recruiting
2019202020212022202320242025202620272028202920302031203220332034203520362037
First PostedNov 28, 2018
Enrollment StartNov 1, 2018
Primary CompletionNov 1, 2033
Study CompletionNov 1, 2036
TodayJul 1, 2026
Enrollment to primary: 15 yearsPosted 7.6 years agoPrimary completion in 7.3 years

Interventions

Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapydrug

vein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and/or Ipilimumab, plus chemotherapy to destroy cancer cells and release tumor antigen for improving CPI therapeutic efficacy.