NCT07321067

Brief Summary

the Objectives of this study are: • Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors. the main question it aims to answer is: What are the clinical outcomes (overall survival, progression-free survival, and OS-ICIs) of immune checkpoint inhibitor therapy in patients with advanced hepatocellular carcinoma? Participants already taking immune checkpoint inhibitors as part of their regular medical care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Nov 2027

First Submitted

Initial submission to the registry

December 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Keywords

advanced hepatocellular carcinomaimmune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

  • ICI-Specific Survival (OS-ICI).

    Time from ICI initiation to death or last follow-up.

    12 months

Study Arms (1)

all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with advanced hepatocellular carcinoma either denovoor after prior line of treatment

You may qualify if:

  • Adults (≥18 years) with radiologically or histologically confirmed advanced HCC
  • Candidates for systemic immune checkpoint inhibitors (e.g., atezolizumab-bevacizumab, durvalumab-tremelimumab).
  • Patients with preserved liver function. ( up to G2 using ALBI score or up to B (7 ) using Child-Pugh socring system) .

You may not qualify if:

  • Child-Pugh C liver function.
  • Prior liver transplantation.
  • patients with concurrent malignancies other than HCC.
  • Active autoimmune disease requiring systemic immunosuppression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag university hospitals

Sohag, Sohag Governorate, 82511, Egypt

Location

sSohag oncology centre

Sohag, Sohag Governorate, 82511, Egypt

Location

Related Publications (10)

  • 10. Cheng, A. L., Rimassa, L., Ducreux, M., et al. (2022). J Hepatol, 76, 862-873.

    BACKGROUND

  • 9. Yau, T., Cheng, A. L., Rimassa, L., et al. (2025). Lancet, 405, 1851-1864.

    BACKGROUND

  • 8. Llovet, J. M., Yau, T., Cheng, A. L., et al. (2008). N Engl J Med, 359, 378-390.

    BACKGROUND

  • 7. Reig, M., Llovet, J. M., Yau, T., et al. (2021). J Hepatol, 76, 681-693.

    BACKGROUND

  • 6. Singal, A. G., Reig, M., Llovet, J. M., et al. (2023). Hepatology, 78, 1922-1965.

    BACKGROUND

  • El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013.

    PMID: 15508094BACKGROUND

  • Kalligeros M, Henry L, Younossi ZM. Metabolic dysfunction-associated steatotic liver disease and its link to cancer. Metabolism. 2024 Nov;160:156004. doi: 10.1016/j.metabol.2024.156004. Epub 2024 Aug 23.

    PMID: 39182603BACKGROUND

  • 3. Liu, Y., Kalligeros, M., El-Serag, H. B., et al. (2022). Cancer Med, 11, 1310-1323.

    BACKGROUND

  • 2. McGlynn, K. A., Liu, Y., Kalligeros, M., et al. (2021). Hepatology, 73, 4-13.

    BACKGROUND

  • 1. Siegel, R. L., McGlynn, K. A., Liu, Y., et al. (2024). CA Cancer J Clin, 74, 12-49.

    BACKGROUND

Central Study Contacts

Ahmed Karam Helmy, MSc

CONTACT

2+01090784895ahmed011028@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Use of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma : efficacy and outcomes

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

EG(2)