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CholangiocarcinomaPhase 2NCT03079427

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

A Phase 2 study testing Gemcitabine plus cisplatin and Capecitabine in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Gemcitabine plus cisplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteSouth Korea
Study dates
15 May 2017to 15 Nov 2022
Phase
Phase 2
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

Who may be able to join

  • Patients aged 19 years and older
  • Histologically documented extrahepatic cholangiocarcinoma (perihilar or distal bile duct tumor)
  • Microscopic or macroscopic surgical resection (ie., R0 or R1 resection)
  • Regional lymph node metastasis according to the American Joint Committee on Cancer (AJCC) 7th edition
  • No distant metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1
Show all 12Show fewer
  • No prior chemotherapy or radiotherapy
  • Serum CA 19-9 < 100 U/mL at the time of enrollment
  • Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L
  • Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
  • Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
  • No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse Written informed consent to the study

Who cannot join

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma
  • Intrahepatic cholangiocarcinoma or gallbladder cancer
  • Obstruction of gastrointestinal tract
  • Active gastrointestinal bleeding
  • Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
  • Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis

There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.

Being tested
Gemcitabine plus cisplatin, Capecitabine
Keywords
Cholangiocarcinoma, Adjuvant chemotherapy
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine plus cisplatinDrug

    Also called Gemcitabine, Cisplatin

    Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks

  • CapecitabineDrug

    Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks

Study groups in NCT03079427
Study groupRoleWhat they receive
CapecitabineActive comparatorAdjuvant Capecitabine
Receives: Drug: Capecitabine
Gemcitabine plus cisplatinExperimentalAdjuvant Gemcitabine plus Cisplatin
Receives: Drug: Gemcitabine plus cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year disease-free survival

    Proportion of patients without disease recurrence after 2 years

    Measured: 2 years

Secondary outcomes (3)

  1. Disease-free survival

    Median time point that 50% of study patients recur

    Measured: 4 years

  2. Toxicities (Adverse events related with chemotherapy)

    Adverse events related with chemotherapy

    Measured: 4 years

  3. Overall survival

    Median time point that 50% of study patients is alive

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start15 May 2017
  3. Primary completion15 Dec 2021
  4. Study completion15 Nov 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079427
Sponsor's protocol ID
Asan-ONCHBP-2017-001
Status last verified
Dec 2022
First submitted
9 Mar 2017
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Horgan AM, Amir E, Walter T, Knox JJ. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012 Jun 1;30(16):1934-40. doi: 10.1200/JCO.2011.40.5381. Epub 2012 Apr 23.

    PubMed 22529261

  • Valle 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 20375404

  • Ramirez-Merino N, Aix SP, Cortes-Funes H. Chemotherapy for cholangiocarcinoma: An update. World J Gastrointest Oncol. 2013 Jul 15;5(7):171-6. doi: 10.4251/wjgo.v5.i7.171.

    PubMed 23919111

  • Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Olah A, Rawcliffe CL, Verbeke CS, Campbell F, Buchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352.

    PubMed 22782416

  • Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. doi: 10.1002/cncr.20368.

    PubMed 15274071

  • Petekkaya I, Gezgen G, Roach EC, Solak M, Gullu I. Long-term advanced cholangiocarcinoma survivor with single-agent capecitabine. J BUON. 2012 Oct-Dec;17(4):796. No abstract available.

    PubMed 23335544

  • Jeong H, Oh JH, Ahn HS, Ryoo BY, Kim KP, Jeong JH, Park I, Hwang DW, Lee JH, Song KB, Lee W, Kim KH, Moon DB, Song GW, Jung DH, Hong SM, Park CW, Baek IP, Cho YS, Kim K, Sung CO, Yoo C. Proteogenomic profiling predicts outcomes of adjuvant chemotherapy in extrahepatic cholangiocarcinoma. J Hepatol. 2026 Jan;84(1):122-134. doi: 10.1016/j.jhep.2025.07.031. Epub 2025 Aug 11.

    PubMed 40803577

  • Yoo C, Jeong H, Jeong JH, Kim KP, Lee S, Ryoo BY, Hwang DW, Lee JH, Moon DB, Kim KH, Lee SS, Song TJ, Oh D, Lee MA, Chon HJ, Lee JS, Laliotis G, Rivero-Hinojosa S, Spickard E, Renner D, Dutta P, Palsuledesai CC, Sharma S, Malhotra M, Jurdi A, Liu MC. Circulating tumor DNA status and dynamics predict recurrence in patients with resected extrahepatic cholangiocarcinoma. J Hepatol. 2025 May;82(5):861-870. doi: 10.1016/j.jhep.2024.10.043. Epub 2024 Nov 10.

    PubMed 39532185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine plus cisplatin and Capecitabine in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Asan Medical Center 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 6 Dec 2022. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year disease-free survival (time frame: 2 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 NCT03079427, which also lists 8 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 6 Dec 2022.

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