Hepatocellular CarcinomaPhase 1KARCHER-1NCT04587739
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
A Phase 1 study testing Surgery with Neoadjuvant stereotactic body radiation therapy in people with Hepatocellular Carcinoma, run by University Hospital, Lille at 1 site in France.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Surgery with Neoadjuvant stereotactic body radiation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2021to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria
- Single nodule, 3 to 8 cm of largest diameter
- Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization
Who cannot join
- Performance status > 2
- Severe comorbidity with contraindication for either surgery or radiation therapy
- Decompensated liver cirrhosis (Child-Pugh B or C)
- Neoplastic portal vein thrombosis or extra-hepatic metastases
- Previous anticancer therapy within the last 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
About this study
Official title: A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".
To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.
Read more
Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.
Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Surgery with Neoadjuvant stereotactic body radiation therapy
- Keywords
- Hepatocellular carcinoma, Stereotactic body radiation therapy, Hepatectomy, Neoadjuvant therapy, Drop-out
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with Neoadjuvant stereotactic body radiation therapyCombination product
Stereotactic hypofractionated robotic radiation therapy (24-45 Gy / 3 fractions) followed after 4-6 weeks by conventional hepatectomy (either anatomical liver resection, or non-anatomical liver resection with intention to achieve a minimal 2 cm margin).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Combination Product: Surgery with Neoadjuvant stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out rate
Drop-out rate: proportion of patients in whom surgical resection cannot be achieved, due to (at least one of the following reasons):
- serious adverse events related to radiation therapy (especially liver decompensation);
- disease progression while receiving radiation therapy or awaiting surgery;
- patient's death.
Measured: Five months after the inclusion of the last participating patient
Secondary outcomes (10)
Intraoperative number of packed red blood cells transfused (if any).
Measured: Postoperative 90 days
Toxicity of radiation therapy using the National Cancer Institute CTCAE v.5.0 criteria
Measured: Postoperative 90 days
Duration of surgery.
Measured: Postoperative 90 days
Volume of intraoperative blood loss
Measured: Postoperative 90 days
Quality of life by EORTC QLQ-C30
Measured: between before and after stereotactic radiotherapy
Intraoperative adverse events
Measured: Postoperative 90 days
Postoperative severe and overall morbidity rate
defined using the Comprehensive Complication Index and graded with the Dindo-Clavien score
Measured: Postoperative 90 days
Postoperative mortality rate.
Measured: Postoperative 90 days
Correlation between radiological observations on preoperative imaging and pathological features on surgical specimen (like percentage of tumor necrosis).
Measured: Postoperative day 30.
Actuarial overall survival and disease-free survival.
Measured: Postoperative 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start31 Jan 2021
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Emmanuel Boleslawski, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587739
- Sponsor's protocol ID
- 2017_03
- Other IDs
- 2019-A01441-56
- Acronym
- KARCHER-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT04587739
- Acronym / sponsor ID
- KARCHER-1 / 2017_03
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Stereotactic body radiation therapy, Hepatectomy, Neoadjuvant therapy, Drop-out
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Oct 2020 (actual)
- 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.
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".
To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.
Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.
Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Surgery with Neoadjuvant stereotactic body radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria
- Single nodule, 3 to 8 cm of largest diameter
- Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization
Key exclusion criteria (5 listed)
- Performance status > 2
- Severe comorbidity with contraindication for either surgery or radiation therapy
- Decompensated liver cirrhosis (Child-Pugh B or C)
- Neoplastic portal vein thrombosis or extra-hepatic metastases
- Previous anticancer therapy within the last 5 years
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 |
|---|---|---|
| Surgery with Neoadjuvant stereotactic body radiation therapyStereotactic hypofractionated robotic radiation therapy (24-45 Gy / 3 fractions) followed after 4-6 weeks by conventional hepatectomy (either anatomical liver resection, or non-anatomical liver resection with intention to achieve a minimal 2 cm margin). | Combination product | Experimental group |
Primary outcome
Drop-out rate
Time frame: Five months after the inclusion of the last participating patient
Drop-out rate: proportion of patients in whom surgical resection cannot be achieved, due to (at least one of the following reasons): * serious adverse events related to radiation therapy (especially liver decompensation); * disease progression while receiving radiation therapy or awaiting surgery; * patient's death.
10 secondary outcomes
Intraoperative number of packed red blood cells transfused (if any).
Time frame: Postoperative 90 days
Toxicity of radiation therapy using the National Cancer Institute CTCAE v.5.0 criteria
Time frame: Postoperative 90 days
Duration of surgery.
Time frame: Postoperative 90 days
Volume of intraoperative blood loss
Time frame: Postoperative 90 days
Quality of life by EORTC QLQ-C30
Time frame: between before and after stereotactic radiotherapy
Intraoperative adverse events
Time frame: Postoperative 90 days
Postoperative severe and overall morbidity rate
Time frame: Postoperative 90 days
Postoperative mortality rate.
Time frame: Postoperative 90 days
Correlation between radiological observations on preoperative imaging and pathological features on surgical specimen (like percentage of tumor necrosis).
Time frame: Postoperative day 30.
Actuarial overall survival and disease-free survival.
Time frame: Postoperative 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Emmanuel Boleslawski, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surgery with Neoadjuvant stereotactic body radiation therapy in people with Hepatocellular Carcinoma, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Boleslawski, MD,PhD (320444260 ext. +33, emmanuel.boleslawski@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out rate (time frame: Five months after the inclusion of the last participating patient). 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 26 Oct 2026.