CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 35 target
Drug / intervention
Maintenance first-line treatment plus radiation therapydrug
Likely dose
Not stated in record
Key inclusion· 11
  • Confirmed HCC by histopathology, cytology, or imaging with cirrhosis
  • Oligoprogression after first-line PD-1 therapy
  • Stable disease for at least 3 months after first-line PD-1 therapy
  • ≤5 lesions in ≤3 organs
Key exclusion· 17
  • Fibrous lamina, sarcomatoid, or cholangiocarcinoma histology
  • History of hepatic encephalopathy or liver transplantation
  • Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
  • Untreated hepatitis: HBV DNA >2000 IU/ml or >10^4 copy/ml, HCV RNA >10^3 copy/ml, or HBsAg/anti-HCV positive

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

Search/NCT06870942
NCT06870942Phase 2RecruitingUpdate OverdueUpdated 15mo ago · Completion was 19mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy: A Phase II Clinical Study

Shanghai Zhongshan Hospital·interventional·Posted Mar 11, 2025·Updated Mar 11, 2025

In Brief

A Phase 2 clinical trial evaluating Maintenance first-line treatment plus radiation therapy for HCC - Hepatocellular Carcinoma and Radiotherapy. Currently recruiting, targeting 35 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

Immune checkpoint inhibitors (ICIs) have significantly improved the survival outcomes of HCC patients. However, a considerable proportion of patients eventually experience disease progression due to the development of resistance. Among these, oligoprogression is a common manifestation, occurring in 10-55.3% of advanced cancer patients. Local therapy, especially radiotherapy (RT), has been increasingly considered in the setting of oligoprogression to overcome ICIs resistance and delay the need to change systemic therapy. Therefore, this study aimed to explore the efficacy and safety of RT in oligoprogressive HCC following first-line PD-1 therapy.

Study Details

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

Timeline

Phase 2RecruitingOverdue
2023202420252026
First PostedMar 11, 2025
Enrollment StartJul 28, 2022
Primary CompletionNov 30, 2024
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 1.3 years ago

Interventions

Maintenance first-line treatment plus radiation therapydrug

Maintenance first-line treatment plus radiation therapy