Costimulatory and co-inhibitory molecules on tumor-infiltrating lymphocytes from hepatocellular carcinoma and cholangiocarcinoma

Recruiting

• Conditions: hepatocellular carcinoma; liver cancer; 10019815

• Registration Number: NL-OMON53120
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 272

Inclusion Criteria

Adult hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCA) patients that
will undergo surgery for this disease

Exclusion Criteria

Patients who refuse blood donation/participation in the study
Patients with a severe immunocompromised condition, or patients taking
immunosuppressive medication

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br>1) Frequencies and absolute numbers of different lymphocyte populations that<br /><br>together compose the tumor-infiltrating lymphocyte pool<br /><br>2) Expression of costimulatory and co-inhibitory molecules on TIL versus<br /><br>lymphocytes isolated from tumor-free tissue versus circulating lymphocytes<br /><br>3) Effect of blocking co-inhibitory molecules or stimulating costimulatory<br /><br>molecules expressed by TIL on their function (proliferation and cytokine<br /><br>production) in ex vivo culture experiments</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Depending on the co-inhibitory molecules detected on TIL, immunohistochemistry<br /><br>will be performed on residual formalin-fixed paraffin-embedded tumor tissue<br /><br>that is regularly stored to identify the expression of the ligands of these<br /><br>co-inhibitory molecules (e.g. PDL-1+2, GAL-9) on tumor (infiltrating) cells.</p><br>