To compare numbers of circulating T cells responding to different tumour-associated and viral antigens, as well plasma concentrations of antibodies against these antigens, before and after therapeutic interventions that destruct or debulk tumour…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of tumour antigens and viral antigens that are target of
naturally occurring T cell and antibody responses upon tumour destruction or
debulking by currently applied therapeutic interventions.
Secondary outcome
None
Background summary
Hepatocellular carcinoma (HCC) is the most prevalent primary liver cancer. HCC
develops most often in patients with liver cirrhosis, and can be caused by
different aetiologies, among which chronic hepatitis B virus (HBV) or
HCV-infection. In addition, HCC can develop in non-cirrhotic livers due to
unknown etiology. For 80% of HCC-patients no curative therapy is currently
available, and HCC is notoriously resistant to chemotherapy. Immunotherapy
represents an attractive alternative treatment option, because it is highly
specific and can induce long-lasting immunological memory that may permanently
prevent tumor recurrence.
Our ultimate goal is to develop innovative therapeutic vaccination protocols
for HCC. To identify immunogenic candidate antigens for inclusion in future
vaccines, we aim in the present study to determine which tumour- and viral
antigens induce spontaneous T-cell and antibody responses in HCC-patients after
treatments that stimulate release of such antigens from tumour tissue or reduce
the immunosuppressive tumour microenvironment. For this purpose, we will
compare systemic T-cell and antibody responses against different tumour- and
viral antigens before and after local tumour destruction by radio-frequency
ablation (RFA), trans-arterial chemo-embolization (TACE), or debulking of
tumour tissue by surgical resection.
Study objective
To compare numbers of circulating T cells responding to different
tumour-associated and viral antigens, as well plasma concentrations of
antibodies against these antigens, before and after therapeutic interventions
that destruct or debulk tumour tissue.
Study design
Cohort study in HCC-patients which are treated by RFA, TACE, or surgical
resection. Blood will be collected before intervention, at 3 and 6 weeks after
intervention to determine primary T-cell and antibody responses, and at 3
months after intervention to determine memory T-cell and antibody responses.
Numbers of CD4+ and CD8+ T cells that respond to different tumour- and viral
antigens will be determined by state-of-the-art ex vivo techniques, and
antigen-specific antibodies will be quantified by ELISA. In addition,
leukocytes and plasma will be stored frozen in a biobank for future studies.
Study burden and risks
Collection of 80 ml blood at 4 time points. Two of these collections will be
done during regular venous drawings for diagnostic purposes. No benefit or high
risk for these patients. Hopefully the results of the study will benefit future
HCC-patients.
s'Gravendijkwal 230
Rotterdam 3015 CN
NL
s'Gravendijkwal 230
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Adult HCC-patients treated with RFA, TACE, or surgical resection in Erasmus MC, who are planned to be followed up in Erasmus MC for at least 3 months after the intervention.
Exclusion criteria
Patients who refuse to participate in the study (refusing blood/tissue donation).
Patients with a severe immunocompromised medical condition, or patients taking immunosuppressing medication.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54160.078.15 |