Extrahepatic CholangiocarcinomaNCT05519319
Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
A study testing RFA, PDT and RFA combined with PDT in people with Extrahepatic Cholangiocarcinoma and Bile Duct Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
- What is being tested?
- RFA, PDT and RFA combined with PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed cholangiocarcinoma;
- unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound（EUS）;
- No previous treatment;
- Adequate bone marrow and organ function (white blood cells>4.0×109/L, hemoglobin>90 g/L, and platelets>75×109/L, serum creatinine<2.0 mg/dl);
- A Karnofsky performance status (KPS) score ≥ 50;
- Signed written informed consent.
Who cannot join
- Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs;
- Coexistent with other malignant tumors;
- Pregnant or nursing women;
- Previous gastrointestinal diversion;
- Participation in another study during the month before enrollment in this study;
- Alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Jianfeng Yang, 13454132186
About this study
Official title: Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.
Read the detailed description
The lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (EHCC). Patients with advanced, unresectable EHCC have a relatively poor prognosis, with a median survival time of 3 to 6 months. The only way to prolong stent patency and survival for patients with unresectable locally advanced EHCC is by active control of tumor development. The only treatment that has consistently demonstrated an improvement in stent patency and overall survival (OS) in cholangiocarcinoma patients is photodynamic therapy (PDT). The popularity of endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.RFA for biliary cholangiocarcinoma has demonstrated safety and effectiveness. Endoscopic RFA has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. The clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.
- Conditions
- Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
- Being tested
- RFA, PDT, RFA combined with PDT
- Keywords
- Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
Also called ERCP guided
RFA will be performed
PDTProcedure or surgery
Also called ERCP guided
PDT will be performed
RFA combined with PDTProcedure or surgery
Also called ERCP guided
RFA and PDT will be performed
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy(PDT) | Active comparator | The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. Receives: Procedure: PDT |
| Radiofrequency ablation(RFA) | Active comparator | An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. Receives: Procedure: RFA |
| RFA+PDT | Active comparator | The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. After that An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. Receives: Procedure: RFA combined with PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the time from initial RFA or PDT to death or the end of the study.
Measured: Three years
Secondary outcomes (2)
Adverse events
Number of patients with adverse events
Measured: Three years
Progression-free survival(PFS)
PFS was measured from therapy until the date of disease progression or death
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extrahepatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519319
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet not decided
Publications
Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.
PubMed 33359435Chen P, Yang T, Shi P, Shen J, Feng Q, Su J. Benefits and safety of photodynamic therapy in patients with hilar cholangiocarcinoma: A meta-analysis. Photodiagnosis Photodyn Ther. 2022 Mar;37:102712. doi: 10.1016/j.pdpdt.2022.102712. Epub 2022 Jan 5.
PubMed 34995788Li Z, Jiang X, Xiao H, Chen S, Zhu W, Lu H, Cao L, Xue P, Li H, Zhang D. Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma. Surg Endosc. 2021 Oct;35(10):5655-5664. doi: 10.1007/s00464-020-08095-1. Epub 2020 Oct 26.
PubMed 33104917Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
PubMed 29342492
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05519319
- Acronym / sponsor ID
- 2023-01
- Conditions
- Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
- Keywords
- Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Aug 2022 (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 median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.
Detailed description
The lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (EHCC). Patients with advanced, unresectable EHCC have a relatively poor prognosis, with a median survival time of 3 to 6 months. The only way to prolong stent patency and survival for patients with unresectable locally advanced EHCC is by active control of tumor development. The only treatment that has consistently demonstrated an improvement in stent patency and overall survival (OS) in cholangiocarcinoma patients is photodynamic therapy (PDT). The popularity of endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.RFA for biliary cholangiocarcinoma has demonstrated safety and effectiveness. Endoscopic RFA has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. The clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three parallel groups
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy(PDT) | Active comparator | Procedure: PDTThe PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. |
| Radiofrequency ablation(RFA) | Active comparator | Procedure: RFAAn RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. |
| RFA+PDT | Active comparator | Procedure: RFA combined with PDTThe PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. After that An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed cholangiocarcinoma;
- unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound（EUS）;
- No previous treatment;
- Adequate bone marrow and organ function (white blood cells>4.0×109/L, hemoglobin>90 g/L, and platelets>75×109/L, serum creatinine<2.0 mg/dl);
- A Karnofsky performance status (KPS) score ≥ 50;
Key exclusion criteria (6 listed)
- Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs;
- Coexistent with other malignant tumors;
- Pregnant or nursing women;
- Previous gastrointestinal diversion;
- Participation in another study during the month before enrollment in this study;
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 |
|---|---|---|
| RFAAlso: ERCP guidedRFA will be performed | Procedure or surgery | Radiofrequency ablation(RFA) |
| PDTAlso: ERCP guidedPDT will be performed | Procedure or surgery | Photodynamic therapy(PDT) |
| RFA combined with PDTAlso: ERCP guidedRFA and PDT will be performed | Procedure or surgery | RFA+PDT |
Primary outcome
Overall survival (OS)
Time frame: Three years
OS was defined as the time from initial RFA or PDT to death or the end of the study.
2 secondary outcomes
Adverse events
Time frame: Three years
Progression-free survival(PFS)
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 33359435Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.
- Results publication: PubMed 34995788Chen P, Yang T, Shi P, Shen J, Feng Q, Su J. Benefits and safety of photodynamic therapy in patients with hilar cholangiocarcinoma: A meta-analysis. Photodiagnosis Photodyn Ther. 2022 Mar;37:102712. doi: 10.1016/j.pdpdt.2022.102712. Epub 2022 Jan 5.
- Results publication: PubMed 33104917Li Z, Jiang X, Xiao H, Chen S, Zhu W, Lu H, Cao L, Xue P, Li H, Zhang D. Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma. Surg Endosc. 2021 Oct;35(10):5655-5664. doi: 10.1007/s00464-020-08095-1. Epub 2020 Oct 26.
- Results publication: PubMed 29342492Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
- Individual participant dataSharing planned: Undecided. Yet not decided
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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.
Xiaofeng Zhang principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA, PDT and RFA combined with PDT in people with Extrahepatic Cholangiocarcinoma and Bile Duct Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
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 6 inclusion and 6 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 21 Feb 2023. 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 China. 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 Jianfeng Yang, Doctor (+8613454132186, yjf-1976@163.com, yjf3303@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Three 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 NCT05519319, which also lists 4 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 21 Feb 2023.