Unresectable CholangiocarcinomaNCT04378023
Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.
An observational study of Unresectable Cholangiocarcinoma, run by Hospital Vall d'Hebron at 1 site in Spain.
Trial summary
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Unresectable Cholangiocarcinoma
- What is being tested?
- Neoadjuvant Chemo-radiotherapy and Liver Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2020to 1 Jun 2027
- How long will I take part?
- 5 Years
- 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: Those patients with unresectable malignant appearing hilar stricture and at least one of the following: * Malignant cytology or histology * CA 19.9>130U/mL without cholangits or/and jaundice * Mass on cross-sectional imaging
Who may be able to join
- Willing and able to provide written consent form
- Age ≤ 70 years-old
- ECOG 0 or 1
- Unresectable hCCA ≤3cm in radial diameter
Who cannot join
- Those patients who have received chemotherapy or radiotherapy previously out of protocol
- Liver, extrahepatic or lymph node metastases
- Previous intent of surgical resection or percutaneous biopsy
- Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.
- Infection no controlled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Barcelona, 08035
Cristina Dopazo, PhD/MD, +34932746000 ext. 6113, cristina.dopazo@vallhebron.cat
About this study
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.
Read the detailed description
A prospective multicentre pilot study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases.
The number of subjects necessary is 34 patients to achieve a power of 82% with a significance level of 0.05 to detect a 40% difference between the estimated 50% survival of those patients who are transplanted and 10% of those patients with hCCA unresectable who are not transplanted. This corresponds to a hazard ratio of 3.3219. Estimated loss to follow-up of 10% of patients.
RADIOLOGICAL EVALUATION
It will be considered unresectable those lesions Bismuth IV with the following criteria (Jarnagin WR, et al. Ann Surg 2001; 234:507; Memorial Sloan Kettering Cancer Center Hilar Cholangiocarcinoma Classification):
- Bilateral extension to second order biliary
- Unilateral extension to second-order biliary radicals AND contralateral portal vein involvement OR contralateral hepatic lobar atrophy
- Main or bilateral portal vein involvement
- Insufficient future liver remnant even after portal embolization
It will be performed the tumoral marker (CA 19.9), multiphase chest-abdomen CT scan, magnetic resonance cholangiopancreatography (MRCP) as well as positon emission tomography (PET)-scan if there is doubts of distant disease and upper endoscopic ultrasound (EUS) in order to rule out any obvious lymph node metastases. A biliary drainage will be placed by percutaneous transhepatic biliary drainage (PTBD) or endoscopic biliary drainage (EBD).
NEOADJUVANT TREATMENT
Neoadjuvant treatment consisting of:
- External beam radiotherapy at a total dose of 50-54 Gy, delivered in 25-27 fractions of 1.8-2 Gy per day over 5 weeks. Dose reduction may be considered if necessary, or stereotactic body radiotherapy (SBRT), to be agreed according to the center's clinical practice.
- Capecitabine will be given concurrently with radiotherapy at a dose of 825 mg/m² orally twice daily, seven days a week.
- Cisplatin 25 mg/m² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle until the time of transplantation (minimum 4 cycles).
As an alternative, neoadjuvant treatment without radiotherapy is proposed:
- Cisplatin 25 mg/m² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle + durvalumab 1500 mg on day 1 of each 21-day cycle for 6 cycles (18 weeks).
Continue treatment for at least eight weeks without durvalumab (minimum 60-day wash-out period), while maintaining gemcitabine-cisplatin. During this period, pre-transplant evaluation is proposed to begin if there is no progression and/or to assess inclusion on the transplant waiting list, depending on the estimated waiting time.
A staging laparotomy/laparoscopy is recommended before including the patient in waiting list for transplant to confirm the abscence of extra-hepatic disease, especially peritoneal seeding and lymph nodes involvement.
A score exception will be allowed to optimized the treatment received and to be transplanted during the first 6 months.
LIVER TRANSPLANT AND FOLLOW-UP
Regarding liver transplant technique, the hepatic artery should be avoided for arterial reconstruction using the splenic artery or an iliac conduit.
NGS analyses in the explant specimen will be performed.
The patient will be monitored post-operatively at the clinical, biological, and morphological levels every 3 months during the first 2 years and every 6 months thereafter, in the context of standard clinical care, to detect any recurrence.
- Conditions
- Unresectable Cholangiocarcinoma
- Being tested
- Neoadjuvant Chemo-radiotherapy, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemo-radiotherapyDrug
Patients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg/m2 bid).Thereafter, gemcitabine iv (1000mg/m2) plus cisplatin iv (25mg/m2) will be administered the day 1 and 8 every 21 days until transplant.
Liver TransplantationProcedure or surgery
If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases Receives: Drug: Neoadjuvant Chemo-radiotherapy; Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 1, 3, and 5 years post-transplant
Measured: 5 years
Secondary outcomes (3)
Recurrence free survival at 1, 3 and 5 years post-transplant
Measured: 5 years
Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year
Measured: 5 years
The rate of patients included in the study who are finally transplanted.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start24 Apr 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unresectable CholangiocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Dopazo Taboada, Hospital Vall d'Hebron
- Investigators
- Sonia Pascual-Bartolomé, Study chair, HOSPITAL GENERAL UNIVERSITARIO, ALICANTECarmelo Loinaz-Segurola, Study chair, HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRIDJosé María Álamo-Martinez, Study chair, HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLAJosé Luis Lucena de la Poza, Study chair, Hospital Universitario Puerta de Hierro MajadahondaArturo Colon-Rodríguez, Study chair, HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRIDDiego López-Segarra, Study chair, COMPLEJO HOSPITALARIO UNIVERSITARIO, BADAJOZYilliam Fundora-Suárez, Study chair, Hospital Clinic of BarcelonaEva Montalvá-Orón, Study chair, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378023
- Sponsor's protocol ID
- CholangioTrans
- Status last verified
- May 2026
- First submitted
- 4 May 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.
PubMed 11573044Heimbach JK, Gores GJ, Haddock MG, Alberts SR, Nyberg SL, Ishitani MB, Rosen CB. Liver transplantation for unresectable perihilar cholangiocarcinoma. Semin Liver Dis. 2004 May;24(2):201-7. doi: 10.1055/s-2004-828896.
PubMed 15192792Rea DJ, Heimbach JK, Rosen CB, Haddock MG, Alberts SR, Kremers WK, Gores GJ, Nagorney DM. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005 Sep;242(3):451-8; discussion 458-61. doi: 10.1097/01.sla.0000179678.13285.fa.
PubMed 16135931Darwish Murad S, Kim WR, Harnois DM, Douglas DD, Burton J, Kulik LM, Botha JF, Mezrich JD, Chapman WC, Schwartz JJ, Hong JC, Emond JC, Jeon H, Rosen CB, Gores GJ, Heimbach JK. Efficacy of neoadjuvant chemoradiation, followed by liver transplantation, for perihilar cholangiocarcinoma at 12 US centers. Gastroenterology. 2012 Jul;143(1):88-98.e3; quiz e14. doi: 10.1053/j.gastro.2012.04.008. Epub 2012 Apr 12.
PubMed 22504095Ethun CG, Lopez-Aguiar AG, Anderson DJ, Adams AB, Fields RC, Doyle MB, Chapman WC, Krasnick BA, Weber SM, Mezrich JD, Salem A, Pawlik TM, Poultsides G, Tran TB, Idrees K, Isom CA, Martin RCG, Scoggins CR, Shen P, Mogal HD, Schmidt C, Beal E, Hatzaras I, Shenoy R, Cardona K, Maithel SK. Transplantation Versus Resection for Hilar Cholangiocarcinoma: An Argument for Shifting Treatment Paradigms for Resectable Disease. Ann Surg. 2018 May;267(5):797-805. doi: 10.1097/SLA.0000000000002574.
PubMed 29064885
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT04378023
- Acronym / sponsor ID
- CholangioTrans
- Conditions
- Unresectable Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 May 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.
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.
Detailed description
A prospective multicentre pilot study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases.
The number of subjects necessary is 34 patients to achieve a power of 82% with a significance level of 0.05 to detect a 40% difference between the estimated 50% survival of those patients who are transplanted and 10% of those patients with hCCA unresectable who are not transplanted. This corresponds to a hazard ratio of 3.3219. Estimated loss to follow-up of 10% of patients.
RADIOLOGICAL EVALUATION
It will be considered unresectable those lesions Bismuth IV with the following criteria (Jarnagin WR, et al. Ann Surg 2001; 234:507; Memorial Sloan Kettering Cancer Center Hilar Cholangiocarcinoma Classification):
- Bilateral extension to second order biliary
- Unilateral extension to second-order biliary radicals AND contralateral portal vein involvement OR contralateral hepatic lobar atrophy
- Main or bilateral portal vein involvement
- Insufficient future liver remnant even after portal embolization
It will be performed the tumoral marker (CA 19.9), multiphase chest-abdomen CT scan, magnetic resonance cholangiopancreatography (MRCP) as well as positon emission tomography (PET)-scan if there is doubts of distant disease and upper endoscopic ultrasound (EUS) in order to rule out any obvious lymph node metastases. A biliary drainage will be placed by percutaneous transhepatic biliary drainage (PTBD) or endoscopic biliary drainage (EBD).
NEOADJUVANT TREATMENT
Neoadjuvant treatment consisting of:
- External beam radiotherapy at a total dose of 50-54 Gy, delivered in 25-27 fractions of 1.8-2 Gy per day over 5 weeks. Dose reduction may be considered if necessary, or stereotactic body radiotherapy (SBRT), to be agreed according to the center's clinical practice.
- Capecitabine will be given concurrently with radiotherapy at a dose of 825 mg/m² orally twice daily, seven days a week.
- Cisplatin 25 mg/m² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle until the time of transplantation (minimum 4 cycles).
As an alternative, neoadjuvant treatment without radiotherapy is proposed:
- Cisplatin 25 mg/m² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle + durvalumab 1500 mg on day 1 of each 21-day cycle for 6 cycles (18 weeks).
Continue treatment for at least eight weeks without durvalumab (minimum 60-day wash-out period), while maintaining gemcitabine-cisplatin. During this period, pre-transplant evaluation is proposed to begin if there is no progression and/or to assess inclusion on the transplant waiting list, depending on the estimated waiting time.
A staging laparotomy/laparoscopy is recommended before including the patient in waiting list for transplant to confirm the abscence of extra-hepatic disease, especially peritoneal seeding and lymph nodes involvement.
A score exception will be allowed to optimized the treatment received and to be transplanted during the first 6 months.
LIVER TRANSPLANT AND FOLLOW-UP
Regarding liver transplant technique, the hepatic artery should be avoided for arterial reconstruction using the splenic artery or an iliac conduit.
NGS analyses in the explant specimen will be performed.
The patient will be monitored post-operatively at the clinical, biological, and morphological levels every 3 months during the first 2 years and every 6 months thereafter, in the context of standard clinical care, to detect any recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Neoadjuvant Chemo-radiotherapy, Procedure: Liver TransplantationPatients with unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients with unresectable malignant appearing hilar stricture and at least one of the following: * Malignant cytology or histology * CA 19.9>130U/mL without cholangits or/and jaundice * Mass on cross-sectional imaging
Key inclusion criteria (4 listed)
- Willing and able to provide written consent form
- Age ≤ 70 years-old
- ECOG 0 or 1
- Unresectable hCCA ≤3cm in radial diameter
Key exclusion criteria (5 listed)
- Those patients who have received chemotherapy or radiotherapy previously out of protocol
- Liver, extrahepatic or lymph node metastases
- Previous intent of surgical resection or percutaneous biopsy
- Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.
- Infection no controlled
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 |
|---|---|---|
| Neoadjuvant Chemo-radiotherapyPatients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg/m2 bid).Thereafter, gemcitabine iv (1000mg/m2) plus cisplatin iv (25mg/m2) will be administered the day 1 and 8 every 21 days until transplant. | Drug | Study group |
| Liver TransplantationIf no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation. | Procedure or surgery | Study group |
Primary outcome
Overall survival at 1, 3, and 5 years post-transplant
Time frame: 5 years
3 secondary outcomes
Recurrence free survival at 1, 3 and 5 years post-transplant
Time frame: 5 years
Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year
Time frame: 5 years
The rate of patients included in the study who are finally transplanted.
Time frame: 5 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 26 May 2026.
- Results publication: PubMed 11573044Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.
- Results publication: PubMed 15192792Heimbach JK, Gores GJ, Haddock MG, Alberts SR, Nyberg SL, Ishitani MB, Rosen CB. Liver transplantation for unresectable perihilar cholangiocarcinoma. Semin Liver Dis. 2004 May;24(2):201-7. doi: 10.1055/s-2004-828896.
- Results publication: PubMed 16135931Rea DJ, Heimbach JK, Rosen CB, Haddock MG, Alberts SR, Kremers WK, Gores GJ, Nagorney DM. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005 Sep;242(3):451-8; discussion 458-61. doi: 10.1097/01.sla.0000179678.13285.fa.
- Results publication: PubMed 22504095Darwish Murad S, Kim WR, Harnois DM, Douglas DD, Burton J, Kulik LM, Botha JF, Mezrich JD, Chapman WC, Schwartz JJ, Hong JC, Emond JC, Jeon H, Rosen CB, Gores GJ, Heimbach JK. Efficacy of neoadjuvant chemoradiation, followed by liver transplantation, for perihilar cholangiocarcinoma at 12 US centers. Gastroenterology. 2012 Jul;143(1):88-98.e3; quiz e14. doi: 10.1053/j.gastro.2012.04.008. Epub 2012 Apr 12.
- Results publication: PubMed 29064885Ethun CG, Lopez-Aguiar AG, Anderson DJ, Adams AB, Fields RC, Doyle MB, Chapman WC, Krasnick BA, Weber SM, Mezrich JD, Salem A, Pawlik TM, Poultsides G, Tran TB, Idrees K, Isom CA, Martin RCG, Scoggins CR, Shen P, Mogal HD, Schmidt C, Beal E, Hatzaras I, Shenoy R, Cardona K, Maithel SK. Transplantation Versus Resection for Hilar Cholangiocarcinoma: An Argument for Shifting Treatment Paradigms for Resectable Disease. Ann Surg. 2018 May;267(5):797-805. doi: 10.1097/SLA.0000000000002574.
- Individual participant dataSharing planned: No
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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.
Sonia Pascual-Bartolomé study chair
HOSPITAL GENERAL UNIVERSITARIO, ALICANTE
Carmelo Loinaz-Segurola study chair
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRID
José María Álamo-Martinez study chair
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA
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 Unresectable Cholangiocarcinoma, run by Hospital Vall d'Hebron at 1 site in Spain.
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 4 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 May 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 Spain. 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 CRISTINA DOPAZO, MD/PhD (+34932746113, cristina.dopazo@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 1, 3, and 5 years post-transplant (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378023, which also lists 5 linked publications.
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 May 2026.