Biliary Tract CancerPhase 3NCT06109779

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

A Phase 3 study testing Rilvegostomig, Capecitabine and Gemcitabine/Cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 176 sites in 21 countries.

Active, not recruiting

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

Official record

Search all trials

Trial summary

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Biliary Tract Cancer
What is being tested?: Rilvegostomig, Capecitabine and Gemcitabine/Cisplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 760 participants
Where: 176 sitesin 21 countries
Study dates: 4 Dec 2023to 3 May 2030
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

Who may be able to join

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
Provision of a tumor sample collected at surgical resection.
Randomization within 12 weeks after resection with adequate healing and removal of drains.
Confirmed to be disease-free by imaging within 28 days prior to randomization.
Eastern Cooperative Oncology Group performance status of 0 or 1

Who cannot join

Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
Any anti-cancer therapy for BTC prior to surgery
Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
Current or prior use of immunosuppressive medication within 14 days before the first dose
Thromboembolic event within 3 months
Active HBV or HCV infection unless treated.

Trial locations and contacts

176 sites in 21 countries.

Country

City, postcode or hospital

176 sites in 21 countries

China29 sites

Research Site
Beijing, 100142
Research Site
Beijing, CN-100730
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610000
Research Site
Chengdu, 610072
Research Site
Deyang, 618000
Research Site
Fuzhou, 350005
Research Site
Guangzhou, 510515
Research Site
Guiyang, 550044
Research Site
Hangzhou, 310009
Research Site
Harbin, 150081
Research Site
Hefei, 230001
Research Site
Hefei, 230601
Research Site
Kunming, 650101
Research Site
Lanzhou, 730000
Research Site
Lishui, 323000
Research Site
Nanchang, 330006
Research Site
Nanjing, 2100008
Research Site
Nanjing, 210029
Research Site
Nanning, 530021
Research Site
Shandong
Research Site
Shanghai, 201114
Research Site
Shenyang, 110004
Research Site
Tianjin, 300060
Research Site
Wuhan, 430071
Research Site
Wuhan, 430079
Research Site
Xi'an, 710061
Research Site
Zhengzhou, 450008

Other trials in China

United States22 sites

Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Birmingham, Alabama, 35233
Research Site
Chicago, Illinois, 60637
Research Site
Commack, New York, 11725
Research Site
Dallas, Texas, 75246
Research Site
Grand Rapids, Michigan, 49503
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32224
Research Site
Kansas City, Kansas, 66160
Research Site
Lexington, Kentucky, 40506
Research Site
Littleton, Colorado, 80129
Research Site
Los Angeles, California, 90089
Research Site
Mineola, New York, 11501
Research Site
New Orleans, Louisiana, 70121
Research Site
Orange, California, 92868
Research Site
Philadelphia, Pennsylvania, 19144
Research Site
Phoenix, Arizona, 85054
Research Site
Rochester, Minnesota, 55905
Research Site
St Louis, Missouri, 63110
Research Site
Stanford, California, 94305
Research Site
Washington D.C., District of Columbia, 20007

Other trials in United States

Germany16 sites

Research Site
Berlin, 13353
Research Site
Bonn, 53127
Research Site
Dortmund, 44137
Research Site
Dresden, 01370
Research Site
Erlangen, 91054
Research Site
Esslingen A. N., 73730
Research Site
Frankfurt, 60488
Research Site
Hamburg, 22763
Research Site
Heidelberg, 69120
Research Site
Leipzig, 4103
Research Site
Lübeck, 23538
Research Site
München, 81377
Research Site
München, 81737
Research Site
Münster, 48129
Research Site
Tübingen, 72076
Research Site
Ulm, 89081

Other trials in Germany

Japan15 sites

Research Site
Hiroshima, 734-8551
Research Site
Kashiwa, 227-8577
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kōtoku, 135-8550
Research Site
Mitaka-shi, 181-8611
Research Site
Nagoya, 464-8681
Research Site
Nagoya, 466-8560
Research Site
Osaka, 541-8567
Research Site
Sendai, 980-8574
Research Site
Suita-shi, 565-0871
Research Site
Toyama, 930-0194
Research Site
Ube, 755-8505
Research Site
Wakayama, 641-8510
Research Site
Yokohama, 236-0004
Research Site
Yokohama, 241-8515

Other trials in Japan

Canada9 sites

Research Site
Halifax, Nova Scotia, B3H 2Y9
Research Site
Kingston, Ontario, K7L 2V7
Research Site
London, Ontario, N6C 2R5
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1J 1Z4
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, VSZ 4E6

Other trials in Canada

Spain9 sites

Research Site
Barcelona, 08036
Research Site
Barcelona, 8035
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28007
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Málaga, 29011
Research Site
Pamplona, 31005
Research Site
Santander, 39008

Other trials in Spain

Brazil8 sites

Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90035-000
Research Site
Porto Alegre, 91350-200
Research Site
Santa Maria, 97015-450
Research Site
Santo André, 09060-870
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01327-001
Research Site
Vitória, 29043-260

Other trials in Brazil

France7 sites

Research Site
Marseille, 13273
Research Site
Montpellier, 34295
Research Site
Pessac, 33604
Research Site
Rennes, 35000
Research Site
Strasbourg, 67033
Research Site
Toulouse, 31059
Research Site
Villejuif, 94800

Other trials in France

India7 sites

Research Site
Delhi, 110088
Research Site
Kolkata, 700094
Research Site
Mumbai, 400012
Research Site
Mysuru, 570017
Research Site
New Delhi, 110076
Research Site
New Delhi, 110085
Research Site
Varanasi, 221005

Other trials in India

Italy7 sites

Research Site
Florence, 50134
Research Site
Milan, 20133
Research Site
Milan, 20162
Research Site
Padova, 35128
Research Site
Pisa, 56126
Research Site
Rozzano, 20089
Research Site
Tricase, Lecce, 73039

Other trials in Italy

Taiwan7 sites

Research Site
Kaohsiung City, 82445
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40447
Research Site
Tainan, 70403
Research Site
Taipei, 10002
Research Site
Taipei, 112
Research Site
Taoyuan, 333

Other trials in Taiwan

South Korea6 sites

Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591

Other trials in South Korea

Thailand6 sites

Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 34000
Research Site
Muang, 50200
Research Site
Naimuang, 30000
Research Site
Si Sa Ket, 33000

Other trials in Thailand

Turkey (Türkiye)6 sites

Research Site
Ankara, 06100
Research Site
Ankara, 06230
Research Site
Antalya, 07100
Research Site
Erzurum, 25240
Research Site
Fatih-Istanbul, 34098
Research Site
Samsun, 55139

Other trials in Turkey (Türkiye)

United Kingdom6 sites

Research Site
Cambridge, CB2 0QQ
Research Site
Edgbaston, B15 2WB
Research Site
Glasgow, Scotland, G12 0YN
Research Site
London, NW3 2QG
Research Site
Manchester, M20 4BX
Research Site
Sutton, SM2 5PT

Other trials in United Kingdom

Poland5 sites

Research Site
Bydgoszcz, 85-796
Research Site
Krakow, 31-501
Research Site
Lublin, 20-080
Research Site
Przemyśl, 37-700
Research Site
Warsaw, 02-034

Other trials in Poland

Australia4 sites

Research Site
Camperdown, 2050
Research Site
Clayton, 3168
Research Site
Murdoch, 6150
Research Site
Westmead, 2145

Other trials in Australia

Belgium4 sites

Research Site
Brussels, 1070
Research Site
Brussels, 1200
Research Site
Edegem, 2650
Research Site
Leuven, 3000

Other trials in Belgium

Denmark1 site

Research Site
Herlev, 2730

Other trials in Denmark

Hong Kong1 site

Research Site
Hong Kong, 999077

Other trials in Hong Kong

Norway1 site

Research Site
Oslo, 0379

Other trials in Norway

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Read the detailed description

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

Conditions: Biliary Tract Cancer
Being tested: Rilvegostomig, Placebo, Capecitabine, Gemcitabine/Cisplatin, S-1 [Tegafur/Oteracil/gimeracil]
Keywords: Adenocarcinoma of the biliary tract, Biliary tract Cancer, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors, Bile duct cancer, Immunotherapy, Cholangiocarcinoma, Rilvegostomig, S-1, Gemcitabine/cisplatin, Capecitabine
Medical subject headings: Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma, Klatskin Tumor, Bile Duct Neoplasms

What participants receive

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

RilvegostomigDrug
Rilvegostomig IV (intravenous) Q3W
PlaceboDrug
Placebo IV (intravenous) Q3W
CapecitabineDrug
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Gemcitabine/CisplatinDrug
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
S-1 [Tegafur/Oteracil/gimeracil]Drug
S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Study groups in NCT06109779
Study group	Role	What they receive
Arm A	Experimental	Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) Receives: Drug: Rilvegostomig; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]
Arm B	Placebo comparator	Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) Receives: Drug: Placebo; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]

What is being measured

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

Recurrence free survival (RFS) for Arm A vs. Arm B
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: Approximately 5 years

Secondary outcomes (1)

Overall Survival (OS) for Arm A vs. Arm B
Overall survival is defined as the time from randomization until the date of death due to any cause.
Measured: up to 7 years

Timeline

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

4 Dec 20233 May 2030

First posted31 Oct 2023
Study start4 Dec 2023
Primary completion2 Jan 2029 (estimated)
Study completion3 May 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 760 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06109779
Sponsor's protocol ID: D7025C00001
Other IDs: 2023-506054-20-00, 2023
Status last verified: Oct 2026
First submitted: 26 Oct 2023
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

All Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
ClinicalTrials.gov ID: NCT06109779
Acronym / sponsor ID: D7025C00001
Conditions: Biliary Tract Cancer
Keywords: Adenocarcinoma of the biliary tract, Biliary tract Cancer, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors, Bile duct cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 760 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Dec 2023 (actual)
Primary completion: 2 Jan 2029 (estimated)
Study completion: 3 May 2030 (estimated)
First posted: 31 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: Rilvegostomig, Drug: Capecitabine, Drug: Gemcitabine/Cisplatin, Drug: S-1 [Tegafur/Oteracil/gimeracil]Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm B	Placebo comparator	Drug: Placebo, Drug: Capecitabine, Drug: Gemcitabine/Cisplatin, Drug: S-1 [Tegafur/Oteracil/gimeracil]Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
Provision of a tumor sample collected at surgical resection.
Randomization within 12 weeks after resection with adequate healing and removal of drains.
Confirmed to be disease-free by imaging within 28 days prior to randomization.
Eastern Cooperative Oncology Group performance status of 0 or 1

Key exclusion criteria (7 listed)

Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
Any anti-cancer therapy for BTC prior to surgery
Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
Current or prior use of immunosuppressive medication within 14 days before the first dose

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
RilvegostomigRilvegostomig IV (intravenous) Q3W	Drug	Arm A
PlaceboPlacebo IV (intravenous) Q3W	Drug	Arm B
CapecitabineCapecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice	Drug	Arm A, Arm B
Gemcitabine/CisplatinGemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle	Drug	Arm A, Arm B
S-1 [Tegafur/Oteracil/gimeracil]S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles	Drug	Arm A, Arm B

Primary outcome

Recurrence free survival (RFS) for Arm A vs. Arm B
Time frame: Approximately 5 years
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.

1 secondary outcome

Overall Survival (OS) for Arm A vs. Arm B
Time frame: up to 7 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 16 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Related trials for Biliary Tract Cancer

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

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.

The record lists no contact. Use the official record to reach the sponsor.

176 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilvegostomig, Capecitabine and Gemcitabine/Cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 176 sites in 21 countries.

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 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in China, United States, Germany, Japan, Canada and 16 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. Some participants in this study may receive a placebo. 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?

Recurrence free survival (RFS) for Arm A vs. Arm B (time frame: Approximately 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 NCT06109779.

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 16 Oct 2026.