Perihilar CholangiocarcinomapCOLANCT06986486
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
An observational study of Perihilar Cholangiocarcinoma and Klatskin Tumor, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perihilar Cholangiocarcinoma, Klatskin Tumor
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 1 Jan 2030
- Phase
- Observational
- 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
Study population: Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation
Who may be able to join
- Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
- Transcatheter biopsy or brush cytology
- CA-19.9 > 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
- Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
- Age between 18 years and 70 years
- Absence of intra- and extrahepatic metastases
Show all 11Show fewer
- Absence of lymph-nodal metastases at any site
- Biliary stenting of all liver districts
- No contraindications to liver transplantation
- No concomitant malignancies or history of other malignancies in the previous 5 years
- Written informed consent
Who cannot join
- Intrahepatic cholangiocarcinoma
- Uncontrolled infection
- Concomitant malignancies or history of other malignancies in the previous 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.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Michigan, 20133
Marianna Maspero, 0223904066 ext. +39, marianna.maspero@istitutotumori.mi.it
Vincenzo Mazzaferro, MD, PhD
About this study
Official title: Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
Read the detailed description
Patients with unresectable pCCA who fit within inclusion criteria will be enrolled in the study. They will undergo staging laparoscopy with nodal sampling at the hepatic hilum. In case of negative staging (no peritoneal carcinomatosis, no positive hilar lymph nodes, negative peritoneal washing), they will receive downstaging with gemcitabine-cisplatin +/- durvalumab for 2 cycles, followed by SBRT, followed by at least 4 other cycles of gemcitabine-cisplatin +/- durvalumab. After downstaging, they will undergo disease restaging and, if at least disease stability is confirmed, they will undergo transplant screening and listing. Treatment with gemcitabine-cisplatin + durvalumab will continue until liver transplant, progression or unacceptable toxicity.
During listing, restaging will be performed every two months with CT scan and/or MRI, molecular markers and FDG-PET. The target interval between listing and transplant should be less than 90 days.
- Conditions
- Perihilar Cholangiocarcinoma, Klatskin Tumor
- Keywords
- liver transplantation, stereotactic body radiation therapy, downstaging
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transplant | Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Measured: 3 years
Secondary outcomes (3)
3-year recurrence-free survival
To evaluate recurrence-free survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Measured: 3 years
Safety and feasibility
To evaluate the safety and feasibility of neoadjuvant SBRT and chemotherapy in patients with unresectable hilar cholangiocarcinoma candidate to liver transplantation, in particular we will describe in detail the therapeutic path of all patients with unresectable pCCA that enter within the downstaging pathway and are evaluated for LT, how many are able to be transplanted within this protocol, and what are the reasons for dropout from the protocol
Measured: 3 years
Quality of life
To evaluate the impact of this treatment strategy and of LT on quality of life in patients with unresectable pCCA. Quality of life will be assessed with validated questionnaires. Questionnaires will be performed at baseline and at 6 months intervals; they will be matched and compared with that of eligible patients recruited within the same study period and receiving non-transplant treatments
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986486
- Sponsor's protocol ID
- 254-24
- Acronym
- pCOLA
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
- ClinicalTrials.gov ID
- NCT06986486
- Acronym / sponsor ID
- pCOLA / 254-24
- Conditions
- Perihilar Cholangiocarcinoma, Klatskin Tumor
- Keywords
- liver transplantation, stereotactic body radiation therapy, downstaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 23 May 2025 (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.
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
Detailed description
Patients with unresectable pCCA who fit within inclusion criteria will be enrolled in the study. They will undergo staging laparoscopy with nodal sampling at the hepatic hilum. In case of negative staging (no peritoneal carcinomatosis, no positive hilar lymph nodes, negative peritoneal washing), they will receive downstaging with gemcitabine-cisplatin +/- durvalumab for 2 cycles, followed by SBRT, followed by at least 4 other cycles of gemcitabine-cisplatin +/- durvalumab. After downstaging, they will undergo disease restaging and, if at least disease stability is confirmed, they will undergo transplant screening and listing. Treatment with gemcitabine-cisplatin + durvalumab will continue until liver transplant, progression or unacceptable toxicity.
During listing, restaging will be performed every two months with CT scan and/or MRI, molecular markers and FDG-PET. The target interval between listing and transplant should be less than 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant | – | –Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation
Key inclusion criteria (11 listed)
- Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
- Transcatheter biopsy or brush cytology
- CA-19.9 > 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
- Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
- Age between 18 years and 70 years
Key exclusion criteria (3 listed)
- Intrahepatic cholangiocarcinoma
- Uncontrolled infection
- Concomitant malignancies or history of 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.
Primary outcome
3-year overall survival
Time frame: 3 years
To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
3 secondary outcomes
3-year recurrence-free survival
Time frame: 3 years
Safety and feasibility
Time frame: 3 years
Quality of life
Time frame: 3 years
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 23 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perihilar Cholangiocarcinoma and Klatskin Tumor, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 11 inclusion and 3 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 23 May 2025. 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?
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 Vincenzo Mazzaferro, MD, PhD (0223902760 ext. +39, vincenzo.mazzaferro@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years). 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 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.