Colorectal CancerNCT02475889
Hepatic RFA Increases T Cell Infiltraion and PD-L1 Expression in Primary Colorecatl Cancer
An observational study of Colorectal Cancer, run by The First People's Hospital of Changzhou.
Trial summary
It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. Read more about this study
- Who is it for?
- Ages 32 to 78 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Hepatic RFA and Primary tumor resection
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 391 consecutive patients with synchronous colorectal cancer liver metastases were initially included in this study. Among of them, 38 patients who received initial hepatic RFA followed by primary tumor resection were identified as RFA group, and the other 40 patients who received initial primary tumor resection were identified as Non-RFA group.
Who may be able to join
- Patients with histologically confirmed asynchronous liver metastases received initial hepatic RFA or initial primary tumor resection.
Who cannot join
- Preoperative CT, RT and other antitumor treatment
- Emergency surgery
- Initial hepatectomy
- No qualified endoscopic biopsy
About this study
Official title: Hepatic Radiofrequency Ablation Increases T Cell Infiltraion and PD-L1 Expression in Primary Tumor in Patients With Synchronous Colorectal Cancer Liver Metastases
It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous CRCLM.
Read the detailed description
Radiofrequency ablation (RFA) is widely used as a local treatment for tumors such as small hepatocellular carcinomas, renal cancer and solitary colorectal cancer liver metastases (CRCLM). RFA induces localized coagulation necrosis and leads to the release of large amounts of cellular debris in situ, which can serve as a source of tumor antigens to elicit host adaptive immune responses against tumors. Several studies on preclinical animal models have shown that localized tumor ablation by RFA can induce systemic T-cell mediated antitumor immunity. Antigen-specific T cell immune responses were also observed in patients with hepatic tumors after RFA therapy. However, the RFA-induced immune responses are not sufficient to prevent tumor recurrence. The underlying mechanisms remain obscure.
Programmed death-ligand 1 (PD-L1), an important immune checkpoint molecule, is often up-regulated on tumor cells and tumor associated myeloid cells. It impairs T cell-mediated immune responses upon engagement with its cognate co-inhibitory receptor PD-1, which is always highly expressed on tumor-infiltrating lymphocytes. PD-L1 expression can be induced by pro-inflammatory cytokines, especially type I interferon (IFN), as an important self-limiting mechanism to prevent rampant autoimmunity. Recent studies show that PD-L1 expression on tumor cells is associated with T cell infiltration, suggesting PD-L1 is actively involved in suppressing antitumor immune responses in the tumor microenvironment (TME). Whether the PD-L1/PD1 axis is involved in modulating the antitumor T cell immune responses induced by RFA is unclear.
The objective of this investigation was to study the RFA-induced immune responses in tumor tissues from cancer patients.
- Conditions
- Colorectal Cancer
- Being tested
- Hepatic RFA, Primary tumor resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic RFAProcedure or surgery
Hepatic RFA was performed under guidace of ultrasonography (US) or computed tomography (CT) before primary tumor resection.
Primary tumor resectionProcedure or surgery
Primary tumor resection were performed pre- or post-RFA for liver metastases.
| Study group | Role | What they receive |
|---|---|---|
| RFA group | patients who received hepatic RFA followed by primary tumor resection were assigned to the RFA group Receives: Procedure: Hepatic RFA; Procedure: Primary tumor resection | |
| Non-RFA group | patients who received initial primary tumor resection without RFA Receives: Procedure: Primary tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of T cell infiltraion in primary tumor
Number of T cell infiltraion in primary tumor was evaluated by immunohistochemical staining
Measured: 2 weeks
PD-L1 expression in primary tumor
PD-L1 expression in primary tumor was evaluated by immunohistochemical staining
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startNov 2007
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangrong Shi, The First People's Hospital of Changzhou
- Investigators
- Changping Wu, M.D., Study chair, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475889
- Sponsor's protocol ID
- RFAOO2
- Status last verified
- Jun 2015
- First submitted
- 6 Jun 2015
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Radiofrequency Ablation Increases T Cell Infiltraion and PD-L1 Expression in Primary Tumor in Patients With Synchronous Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT02475889
- Acronym / sponsor ID
- RFAOO2
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous CRCLM.
Detailed description
Radiofrequency ablation (RFA) is widely used as a local treatment for tumors such as small hepatocellular carcinomas, renal cancer and solitary colorectal cancer liver metastases (CRCLM). RFA induces localized coagulation necrosis and leads to the release of large amounts of cellular debris in situ, which can serve as a source of tumor antigens to elicit host adaptive immune responses against tumors. Several studies on preclinical animal models have shown that localized tumor ablation by RFA can induce systemic T-cell mediated antitumor immunity. Antigen-specific T cell immune responses were also observed in patients with hepatic tumors after RFA therapy. However, the RFA-induced immune responses are not sufficient to prevent tumor recurrence. The underlying mechanisms remain obscure.
Programmed death-ligand 1 (PD-L1), an important immune checkpoint molecule, is often up-regulated on tumor cells and tumor associated myeloid cells. It impairs T cell-mediated immune responses upon engagement with its cognate co-inhibitory receptor PD-1, which is always highly expressed on tumor-infiltrating lymphocytes. PD-L1 expression can be induced by pro-inflammatory cytokines, especially type I interferon (IFN), as an important self-limiting mechanism to prevent rampant autoimmunity. Recent studies show that PD-L1 expression on tumor cells is associated with T cell infiltration, suggesting PD-L1 is actively involved in suppressing antitumor immune responses in the tumor microenvironment (TME). Whether the PD-L1/PD1 axis is involved in modulating the antitumor T cell immune responses induced by RFA is unclear.
The objective of this investigation was to study the RFA-induced immune responses in tumor tissues from cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA group | – | Procedure: Hepatic RFA, Procedure: Primary tumor resectionpatients who received hepatic RFA followed by primary tumor resection were assigned to the RFA group |
| Non-RFA group | – | Procedure: Primary tumor resectionpatients who received initial primary tumor resection without RFA |
Who may qualify
- Ages
- 32 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 391 consecutive patients with synchronous colorectal cancer liver metastases were initially included in this study. Among of them, 38 patients who received initial hepatic RFA followed by primary tumor resection were identified as RFA group, and the other 40 patients who received initial primary tumor resection were identified as Non-RFA group.
Key inclusion criteria (1 listed)
- Patients with histologically confirmed asynchronous liver metastases received initial hepatic RFA or initial primary tumor resection.
Key exclusion criteria (4 listed)
- Preoperative CT, RT and other antitumor treatment
- Emergency surgery
- Initial hepatectomy
- No qualified endoscopic biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic RFAHepatic RFA was performed under guidace of ultrasonography (US) or computed tomography (CT) before primary tumor resection. | Procedure or surgery | RFA group |
| Primary tumor resectionPrimary tumor resection were performed pre- or post-RFA for liver metastases. | Procedure or surgery | Non-RFA group, RFA group |
Primary outcome
Number of T cell infiltraion in primary tumor
Time frame: 2 weeks
Number of T cell infiltraion in primary tumor was evaluated by immunohistochemical staining
PD-L1 expression in primary tumor
Time frame: 2 weeks
PD-L1 expression in primary tumor was evaluated by immunohistochemical staining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changping Wu, M.D. study chair
The First People's Hospital of Changzhou
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by The First People's Hospital of Changzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of T cell infiltraion in primary tumor (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.