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CholangiocarcinomaPhase 3ACTICCA-1NCT02170090

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

A Phase 3 study testing Gemcitabine, Cisplatin and Capecitabine in people with Cholangiocarcinoma and Gall Bladder Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 67 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma, Gall Bladder Carcinoma
What is being tested?
Gemcitabine, Cisplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
789 participants
Where
67 sitesin 8 countries
Study dates
Apr 2014to Dec 2025
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during surgery) will be evaluated for eligibility.

  • Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (HCC/CCA) are excluded)
  • Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
  • ECOG 0-1
  • Age ≥18 years
  • Adequate hematologic function
  • Adequate liver function
  • Adequate renal function
  • No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
  • No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
  • Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded)

Criteria for initial study enrolment

  • Written informed consent
  • No prior chemotherapy for cholangiocarcinoma
  • No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
  • No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia)
  • Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
  • No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
  • Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
  • No pregnancy or lactation

Trial locations and contacts

67 sites in 8 countries.

67 sites in 8 countries

United Kingdom24 sites

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke

  • Queen Elizabeth Hospital Birmingham

    Birmingham

  • Royal Bournemouth Hospital

    Bournemouth

  • Bristol Haematology and Oncology Centre

    Bristol

  • Addenbrooke's Hospital Cambridge

    Cambridge

  • Velindre Hospital Cardiff

    Cardiff

  • Western General Hospital Edinburgh

    Edinburgh

  • Beatson West of Scotland Cancer Centre Glasgow

    Glasgow

  • James Paget University Hospitals

    Great Yarmouth

  • Royal Surrey County Hospital Guildford

    Guildford

  • Princess Alexandra Hospital

    Harlow

  • Huddersfield Royal Infirmary

    Huddersfield

  • Guy's and St Thomas's Hospital London

    London

  • Hammersmith Hospital London

    London

  • Royal Free Hospital London

    London

  • University College London Hospital

    London

  • Maidstone Hospital

    Maidstone

  • Christie Hospital Manchester

    Manchester

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • Churchill Hospital Oxford

    Oxford

  • Derriford Hospital Plymouth

    Plymouth

  • Weston Park Hospital Sheffield

    Sheffield

  • Southampton General Hospital

    Southampton

Other trials in United Kingdom

Germany19 sites

  • University Medical Center Aachen

    Aachen

  • Charite Berlin

    Berlin

  • University Medical Center Carl Gustav Carus

    Dresden

  • University Medical Center Essen

    Essen

  • Klinikum Esslingen

    Esslingen am Neckar

  • University of Frankfurt

    Frankfurt

  • University Medical Center Freiburg

    Freiburg im Breisgau

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • University of Hannover

    Hanover

  • University of Heidelberg

    Heidelberg

  • University of Saarland

    Homburg

  • University Medical Center Jena

    Jena

  • Johannes Gutenberg University of Mainz

    Mainz

  • University of Mannheim

    Mannheim

  • University of Munich Grosshadern

    Munich

  • University of Regensburg

    Regensburg

  • University Medical Center Tuebingen

    Tübingen

  • University of Ulm

    Ulm

  • University Medical Center

    Würzburg

Other trials in Germany

Australia12 sites

  • Bankstown Hospital

    Bankstown, New South Wales

  • Flinders Medical Centre

    Bedford Park, South Australia

  • Townsville Hospital

    Douglas, Queensland

  • Royal Brisbane and Women's Hospital

    Herston, Queensland

  • Nepean Hospital Cancer Care

    Kingswood, New South Wales

  • St. George Hospital

    Kogarah, New South Wales

  • Fiona Stanley Hospital Perth

    Murdoch, Western Australia, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • Prince of Wales Hospital

    Randwick, New South Wales

  • St. John of God

    Subiaco, Western Australia, 6008

  • Calvary Mater Newcastle

    Waratah, New South Wales

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

Italy5 sites

  • Istituto Nazionale dei Tumori

    Milan

  • Ospedale San Raffaele

    Milan

  • Istituto Oncologico Veneto IRCCS

    Padova, Padova, 35128

  • Azienda Ospedaliero Medica 2 Universitaria

    Pisa, Pisa, 56126

  • Fondazione Policlinico Gemelli, Roma

    Rome, Rome

Other trials in Italy

Netherlands4 sites

  • Academic Medical Center

    Amsterdam

  • University Medical Center

    Maastricht

  • Erasmus Medisch Centrum

    Rotterdam

  • Universitair Medisch Centrum Utrecht

    Utrecht

Other trials in Netherlands

Austria1 site

  • Kaiser-Franz-Josef Hospital

    Vienna, 1030

Other trials in Austria

Denmark1 site

  • Vejle Hospital

    Vejle

Other trials in Denmark

New Zealand1 site

  • Auckland Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.

Read the detailed description

The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant number 70110215, 70112047). With respect to data obtained in the ABC-02 trial, the combination of cisplatin and gemcitabine for 24 weeks as investigational treatment was selected. Based on adjuvant trials in pancreatic cancer (e.g. ESPAC IV) with a comparable postoperative recovery time, inclusion of patients within a maximum interval of 16 weeks between surgery and start of CTx was chosen. Gemcitabine and cisplatin has a relevantly higher cumulative dose of gemcitabine 18 vs. 12 applications and may thus be of increased efficacy compared to the gemcitabine/oxaliplatin regimen applied in the PRODIGE 12 trial.

Based on the data of the BILCAP trial showing an improvement in median overall survival for capecitabine compared to observation alone presented at the annual meeting of the American Society of Clinical Oncology on June 4th 2017 in Chicago by the British BILCAP trial group, capecitabine has evolved as the new standard of care after curative intent resection of biliary tract cancer.

Based on these data the comparative efficacy of gemcitabine/cisplatin and capecitabine had to be established.

Therefore, the ACTICCA trial was amended to compare gemcitabine and cisplatin to the newly established standard regimen in the adjuvant setting capecitabine, aiming for superiority of the combination regimen vs. the oral monotherapy This was based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications as in BILCAP, including dose calculation and patient diary.

As data of recent trials like the French PRODIGE 12/ACCORD 18 trial have clearly shown that in terms of efficacy of an adjuvant chemotherapy there is no difference between cholangiocarcinoma and gall bladder carcinoma, these two subtypes are pooled and location was added as an stratification factor.

Randomization will be 1:1 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the experimental arm and standard of care (capecitabine) and observation in the control arm.

The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.

Keywords
adjuvant chemotherapy, cholangiocarcinoma, muscle invasive gall bladder carcinoma, translational research, multidisciplinary, AIO, DGAV, DGVS
Medical subject headings
Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

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

Study groups in NCT02170090
Study groupRoleWhat they receive
Gemcitabine plus CisplatinExperimentalChemotherapy will be administered on days 1 and 8 every 3 weeks, Cisplatin (25 mg per square meter of body-surface area) and Gemcitabine (1000 mg per square meter) for 24 weeks (8 cycles) and Observation
Receives: Drug: Gemcitabine; Drug: Cisplatin
CapecitabineActive comparatorCapecitabine will be administered from day 1 to 14 every 3 weeks (1250 mg per square meter of body-surface area, twice daily) for 24 weeks (8 cycles) and Observation
Receives: Drug: Capecitabine

What is being measured

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

  1. Disease free survival (DFS)

    DFS

    Measured: Disease free survival rate at 24 months (DFSR@24)

Secondary outcomes (9)

  1. Disease free survival rate at 24 months (DFSR@24)

    DSFR

    Measured: 24 months

  2. Recurrence free survival

    RFS

    Measured: 24 months

  3. Overall survival

    OS

    Measured: 84 months

  4. Safety and tolerability (assessed by the rate of patients with adverse events according to NCI CTC AE v4.03)

    Measured: 24 months

  5. Quality of life

    QOL

    Measured: 48 months

  6. Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD)

    Measured: 48 months

  7. Rate and severity of biliary tract infections

    Measured: 48 months

  8. Patterns of disease recurrence

    Measured: 48 months

  9. locoregional control (assessed by the rate of patients with hepatic or locoregional recurrence)

    Measured: 48 months

Timeline

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

  1. First posted23 Jun 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02170090
Sponsor's protocol ID
ACTICCA-1
Other IDs
2024-517340-61-00, ACTRN12615001283561
Acronym
ACTICCA-1
Status last verified
Mar 2025
First submitted
18 Jun 2014
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Stein A, Arnold D, Bridgewater J, Goldstein D, Jensen LH, Klumpen HJ, Lohse AW, Nashan B, Primrose J, Schrum S, Shannon J, Vettorazzi E, Wege H. Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial. BMC Cancer. 2015 Jul 31;15:564. doi: 10.1186/s12885-015-1498-0.

    PubMed 26228433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Cisplatin and Capecitabine in people with Cholangiocarcinoma and Gall Bladder Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 67 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United Kingdom, Germany, Australia, Italy, Netherlands and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

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?

Disease free survival (DFS) (time frame: Disease free survival rate at 24 months (DFSR@24)). 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 NCT02170090, which also lists 1 linked publication.

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 30 Mar 2025.

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