Locally Advanced CholangiocarcinomaNCT05677217
Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Locally Advanced Cholangiocarcinoma
An observational study of Locally Advanced Cholangiocarcinoma, run by CHA University at 1 site in South Korea.
Trial summary
The objective of this observational study is to identify patients with locally advanced cholangiocarcinoma treated with nab-paclitaxel and gemcitabine-cisplatin chemotherapy. In this clinical study, peripheral blood and tumor tissues will be analyzed at baseline and every 3 cycles after systemic drug treatment in… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced Cholangiocarcinoma
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2023to 30 Nov 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment of advanced cholangiocarcinoma patients through a competitive registration process at CHA Bundang Hospital, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.
Who may be able to join
- Those above the age of 19 who understand the purpose of the study and agree to participate in the collection of samples during the study.
- Patients with histologically or cytologically confirmed inoperable locally advanced cholangiocarcinoma (gallbladder cancer, extrahepatic biliary tract cancer, intrahepatic biliary tract cancer)
- Patients who underwent an NGS test with advanced cholangiocarcinoma tissues
- Patients planning to be treated with nab-paclitaxel plus gemcitabine-cisplatin combination therapy
- ECOG performance status 0 or 1
Who cannot join
- Systemic condition accompanied by instability of vital signs such as infection or organ failure
- Patients who have previously received palliative chemotherapy for cholangiocarcinoma
- Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
- Those who are assessed as not suitable for this study, at the discretion of the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Hong Jae Chon, MD, PhD, 82-31-780-3928, minidoctor@cha.ac.kr
About this study
Official title: Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Patients With Locally Advanced Cholangiocarcinoma and Discovery of Biomarkers
The objective of this observational study is to identify patients with locally advanced cholangiocarcinoma treated with nab-paclitaxel and gemcitabine-cisplatin chemotherapy.
In this clinical study, peripheral blood and tumor tissues will be analyzed at baseline and every 3 cycles after systemic drug treatment in patients with locally advanced cholangiocarcinoma, and correlation with treatment was analyzed. This is an exploratory study to discover biomarkers that are highly correlated with treatment response.
Read the detailed description
Although surgical treatment is the only treatment for cholangiocarcinoma, most patients are diagnosed at a metastatic or locally advanced stage, and palliative chemotherapy is the main treatment method for this group of patients.
Recently, with the introduction of gemcitabine, cisplatin, and nab-paclitaxel combination chemotherapy for locally advanced cholangiocarcinoma, the treatment response rate is improving, and the number of cases of downgrade to an operable state is increasing.
However, there are no prospective studies confirming the rate of conversion surgery after gemcitabine, cisplatin, and Nab-paclitaxel combination therapy in locally advanced cholangiocarcinoma. As a result of long-term follow-up, more than 30% of patients relapsed, so it is urgent to develop predictive biomarkers before surgery.
There are reports that tumor DNA (ctDNA) accurately predicts recurrence after surgical treatment. Using blood samples that are relatively easy to collect compared to biopsies, it is possible to quantitatively measure tumor burden and to evaluate the effectiveness of systemic treatments such as chemotherapy. It is a very popular tool for measuring and predicting the success of surgical treatment in advanced solid cancer.
The purpose of this study was to determine the rate of conversion surgery after treatment with Gemcitabine, Cisplatin, and Nab-paclitaxel in patients with inoperable locally advanced cholangiocarcinoma through an observational study. In addition, the purpose of this study is to verify the performance of biomarkers in predicting recurrence and survival after ctDNA and RNA conversion surgery in a situation where there is no clinical strategy to select a group of patients who can try radical resection.
- Conditions
- Locally Advanced Cholangiocarcinoma
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 |
|---|---|---|
| nab-paclitaxel plus gemcitabine-cisplatin | gemcitabine, 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 100 mg/m2, on days 1 and 8 of 21-day cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion Surgery Rate
Proportion of patients who underwent conversion surgery
Measured: 6 months
Secondary outcomes (3)
OS
Overall survival is calculated as the time from initiation of treatment until death.
The follow-up period is from initiation of treatment until the date of death or for 1 year after last patient enrollment, whichever is earlier.
Measured: 2 years
ORR
Overall Response Rate follow-up will be conducted every 6 weeks. Lesion will be evaluated according to RECIST 1.1 (CR, complete disappearance or LN short axis diameter < 1.0cm; PR, ≥30% reduction; PD, ≥20% increase; SD, neither CR, PR nor PD).
The follow-up period is from initiation of treatment until date of disease progression or death or for 1 year after last patient enrollment, whichever is earlier.
Measured: 1 year
PFS
Progression Free Survival is calculated as the time from initiation of treatment until the date of disease progression or death without PD.
The follow-up period is from initiation of treatment until the date of disease progression or death without PD or for 1 year after last patient enrollment, whichever is earlier.
Each time ORR is measured at 2-month intervals, progression-free survival will be checked.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jae Chon, MD,PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677217
- Sponsor's protocol ID
- 2022-11-002
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 11573044Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
PubMed 20375404Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS, Park DH, Song TJ, Seo DW, Lee SK, Kim MH, Park JH, Cho H, Ryoo BY, Chang HM. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017 Jul;80(1):209-215. doi: 10.1007/s00280-017-3353-2. Epub 2017 Jun 8.
PubMed 28597043Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.
PubMed 30998813Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.
PubMed 35657320Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
PubMed 27384348Cheon J, Lee CK, Sang YB, Choi HJ, Kim MH, Ji JH, Ko KH, Kwon CI, Kim DJ, Choi SH, Kim C, Kang B, Chon HJ. Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis. Ther Adv Med Oncol. 2021 Aug 7;13:17588359211035983. doi: 10.1177/17588359211035983. eCollection 2021.
PubMed 34394748
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Patients With Locally Advanced Cholangiocarcinoma and Discovery of Biomarkers
- ClinicalTrials.gov ID
- NCT05677217
- Acronym / sponsor ID
- 2022-11-002
- Conditions
- Locally Advanced Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
The objective of this observational study is to identify patients with locally advanced cholangiocarcinoma treated with nab-paclitaxel and gemcitabine-cisplatin chemotherapy.
In this clinical study, peripheral blood and tumor tissues will be analyzed at baseline and every 3 cycles after systemic drug treatment in patients with locally advanced cholangiocarcinoma, and correlation with treatment was analyzed. This is an exploratory study to discover biomarkers that are highly correlated with treatment response.
Detailed description
Although surgical treatment is the only treatment for cholangiocarcinoma, most patients are diagnosed at a metastatic or locally advanced stage, and palliative chemotherapy is the main treatment method for this group of patients.
Recently, with the introduction of gemcitabine, cisplatin, and nab-paclitaxel combination chemotherapy for locally advanced cholangiocarcinoma, the treatment response rate is improving, and the number of cases of downgrade to an operable state is increasing.
However, there are no prospective studies confirming the rate of conversion surgery after gemcitabine, cisplatin, and Nab-paclitaxel combination therapy in locally advanced cholangiocarcinoma. As a result of long-term follow-up, more than 30% of patients relapsed, so it is urgent to develop predictive biomarkers before surgery.
There are reports that tumor DNA (ctDNA) accurately predicts recurrence after surgical treatment. Using blood samples that are relatively easy to collect compared to biopsies, it is possible to quantitatively measure tumor burden and to evaluate the effectiveness of systemic treatments such as chemotherapy. It is a very popular tool for measuring and predicting the success of surgical treatment in advanced solid cancer.
The purpose of this study was to determine the rate of conversion surgery after treatment with Gemcitabine, Cisplatin, and Nab-paclitaxel in patients with inoperable locally advanced cholangiocarcinoma through an observational study. In addition, the purpose of this study is to verify the performance of biomarkers in predicting recurrence and survival after ctDNA and RNA conversion surgery in a situation where there is no clinical strategy to select a group of patients who can try radical resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel plus gemcitabine-cisplatin | – | –gemcitabine, 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 100 mg/m2, on days 1 and 8 of 21-day cycles |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of advanced cholangiocarcinoma patients through a competitive registration process at CHA Bundang Hospital, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.
Key inclusion criteria (5 listed)
- Those above the age of 19 who understand the purpose of the study and agree to participate in the collection of samples during the study.
- Patients with histologically or cytologically confirmed inoperable locally advanced cholangiocarcinoma (gallbladder cancer, extrahepatic biliary tract cancer, intrahepatic biliary tract cancer)
- Patients who underwent an NGS test with advanced cholangiocarcinoma tissues
- Patients planning to be treated with nab-paclitaxel plus gemcitabine-cisplatin combination therapy
- ECOG performance status 0 or 1
Key exclusion criteria (4 listed)
- Systemic condition accompanied by instability of vital signs such as infection or organ failure
- Patients who have previously received palliative chemotherapy for cholangiocarcinoma
- Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
- Those who are assessed as not suitable for this study, at the discretion of the researcher
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
Conversion Surgery Rate
Time frame: 6 months
Proportion of patients who underwent conversion surgery
3 secondary outcomes
OS
Time frame: 2 years
ORR
Time frame: 1 year
PFS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: 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.
- Background: PubMed 20375404Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
- Background: PubMed 28597043Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS, Park DH, Song TJ, Seo DW, Lee SK, Kim MH, Park JH, Cho H, Ryoo BY, Chang HM. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017 Jul;80(1):209-215. doi: 10.1007/s00280-017-3353-2. Epub 2017 Jun 8.
- Background: PubMed 30998813Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.
- Background: PubMed 35657320Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.
- Background: PubMed 27384348Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
- Background: PubMed 34394748Cheon J, Lee CK, Sang YB, Choi HJ, Kim MH, Ji JH, Ko KH, Kwon CI, Kim DJ, Choi SH, Kim C, Kang B, Chon HJ. Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis. Ther Adv Med Oncol. 2021 Aug 7;13:17588359211035983. doi: 10.1177/17588359211035983. eCollection 2021.
- 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. This study is not recruiting at the moment.
Hong Jae Chon, MD,PhD principal investigator
CHA Bundang Medical Center
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 Locally Advanced Cholangiocarcinoma, run by CHA University at 1 site in South Korea.
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 5 inclusion and 4 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 7 Feb 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 South Korea. 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 Hong Jae Chon, MD,PhD (82-031-780-3928, minidoctor@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion Surgery Rate (time frame: 6 months). 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 NCT05677217, which also lists 7 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 7 Feb 2024.