Liver MetastasesRAPID-PadovaNCT04865471
Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
A study testing Liver transplantation in people with Liver Metastases, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to Oct 2025
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and <70 years
- Performance status, ECOG 0-1
- Histologically proved adenocarcinoma in colon or rectum
- BRAF wild-type CRC on primary tumor or liver metastases
- High standard oncological surgical resection of the primary tumor
- Liver metastases not eligible for curative liver resection confirmed by the validation committee
Show all 13Show fewer
- At least one line (3 months) of chemotherapy
- At least 6 months time span from CRC resection and date of being listed on the transplantation list.
- At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
- No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
- Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
- CEA stable or in decrease
- Signed informed consent and expected cooperation of the patients for the treatment and follow up
Who cannot join
- Weight loss >10% the last 6 months
- Patient BMI > 30
- Participation refusal
- General contraindication to LT
- Other malignancies in the previous 5 years
- Pregnancy or breast feeding
- Any reason why, in the opinion of the investigator, the patient should not participate
Trial locations and contacts
1 site in 1 country.
Sara Lonardi, MD contact
Italy1 site, 1 recruiting
- Recruiting
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padova, 35128
Umberto Cillo, MD, cillo@unipd.it
About this study
Official title: Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.
- Conditions
- Liver Metastases
- Being tested
- Liver transplantation
- Keywords
- Colorectal Liver Metastases, Auxiliary Liver Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Auxiliary liver transplantation and staged hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Experimental | Auxiliary liver transplantation and staged hepatectomy Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
Rate of second stage hepatectomy performed within 4 weeks from transplatation
Measured: within 4 weeks from liver transplantation
Secondary outcomes (5)
Intention to treat survival after liver transplantation
Time from transplantation to either death or censoring
Measured: 3 and 5 years
Progression free survival
Time from enrolement to either progression or censoring
Measured: 3 and 5 years
Proportion of drop out
Rate of drop out from listing
Measured: within 100 days from listing
Mortality
Rate of death within 90 days after second stage hepatectomy
Measured: within 90 days from second stage hepatectomy
Complication rate
Complications according to Dindo Clavien Classification
Measured: within 90 days after liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Oct 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865471
- Sponsor's protocol ID
- AOP1838
- Acronym
- RAPID-Padova
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT04865471
- Acronym / sponsor ID
- RAPID-Padova / AOP1838
- Conditions
- Liver Metastases
- Keywords
- Colorectal Liver Metastases, Auxiliary Liver Transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Apr 2021 (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.
RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | Experimental | Procedure: Liver transplantationAuxiliary liver transplantation and staged hepatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥ 18 and <70 years
- Performance status, ECOG 0-1
- Histologically proved adenocarcinoma in colon or rectum
- BRAF wild-type CRC on primary tumor or liver metastases
- High standard oncological surgical resection of the primary tumor
Key exclusion criteria (7 listed)
- Weight loss >10% the last 6 months
- Patient BMI > 30
- Participation refusal
- General contraindication to LT
- Other malignancies in the previous 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 |
|---|---|---|
| Liver transplantationAuxiliary liver transplantation and staged hepatectomy | Procedure or surgery | Liver transplantation |
Primary outcome
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
Time frame: within 4 weeks from liver transplantation
Rate of second stage hepatectomy performed within 4 weeks from transplatation
5 secondary outcomes
Intention to treat survival after liver transplantation
Time frame: 3 and 5 years
Progression free survival
Time frame: 3 and 5 years
Proportion of drop out
Time frame: within 100 days from listing
Mortality
Time frame: within 90 days from second stage hepatectomy
Complication rate
Time frame: within 90 days after liver transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Sara Lonardi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation in people with Liver Metastases, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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 13 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cillo, MD (049.8212211-1897 ext. +39, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation (time frame: within 4 weeks from liver transplantation). 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 23 Apr 2024.