New drug aims to stop bile duct cancer from returning after surgery

NCT ID NCT06109779

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This global phase 3 trial is testing whether adding the immunotherapy drug rilvegostomig to standard chemotherapy can help prevent biliary tract cancer from coming back after surgery. About 757 people who had their cancer completely removed will receive either rilvegostomig or a placebo, along with chemo. The study is currently active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: rilvegostomig (an immunotherapy drug given intravenously)
What this could lead to: If successful, this could offer a new treatment option to help prevent biliary tract cancer from coming back after surgery.
What could go wrong: This is a phase 3 trial, but results are not yet available. The drug may not improve outcomes over standard chemo alone, and immunotherapy can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

760 people

The number who actually took part.

Started

Dec 2023

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

bile duct neoplasm biliary tract cancer Biliary Tract Neoplasms cholangiocarcinoma extrahepatic bile duct carcinoma gallbladder cancer gallbladder neoplasm hilar cholangiocarcinoma intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35233, United States
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Phoenix, Arizona, 85054, United States
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Los Angeles, California, 90089, United States
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Orange, California, 92868, United States
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Stanford, California, 94305, United States
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Aurora, Colorado, 80045, United States
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Littleton, Colorado, 80129, United States
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Washington D.C., District of Columbia, 20007, United States
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Jacksonville, Florida, 32224, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60637, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Lexington, Kentucky, 40506, United States
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New Orleans, Louisiana, 70121, United States
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Grand Rapids, Michigan, 49503, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Commack, New York, 11725, United States
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Mineola, New York, 11501, United States
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Philadelphia, Pennsylvania, 19144, United States
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Dallas, Texas, 75246, United States
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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Murdoch, 6150, Australia
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Westmead, 2145, Australia
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Natal, 59075-740, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santa Maria, 97015-450, Brazil
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Santo André, 09060-870, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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Vitória, 29043-260, Brazil
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Vancouver, British Columbia, VSZ 4E6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Kingston, Ontario, K7L 2V7, Canada
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London, Ontario, N6C 2R5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Beijing, 100142, China
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Beijing, CN-100730, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Deyang, 618000, China
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Fuzhou, 350005, China
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Guangzhou, 510515, China
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Guiyang, 550044, China
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Hangzhou, 310009, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230601, China
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Kunming, 650101, China
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Lanzhou, 730000, China
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Lishui, 323000, China
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Nanchang, 330006, China
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Nanjing, 2100008, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shandong, China
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Shanghai, 201114, China
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Shenyang, 110004, China
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Tianjin, 300060, China
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Wuhan, 430071, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Herlev, 2730, Denmark
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Marseille, 13273, France
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Montpellier, 34295, France
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Pessac, 33604, France
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Rennes, 35000, France
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Strasbourg, 67033, France
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Toulouse, 31059, France
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Villejuif, 94800, France
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Dortmund, 44137, Germany
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Dresden, 01370, Germany
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Erlangen, 91054, Germany
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Esslingen A. N., 73730, Germany
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Frankfurt, 60488, Germany
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Hamburg, 22763, Germany
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Heidelberg, 69120, Germany
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Leipzig, 4103, Germany
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Lübeck, 23538, Germany
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München, 81377, Germany
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München, 81737, Germany
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Münster, 48129, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Hong Kong, 999077, Hong Kong
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Shatin, 00000, Hong Kong
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Delhi, 110088, India
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Kolkata, 700094, India
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Mumbai, 400012, India
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Mysuru, 570017, India
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New Delhi, 110076, India
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New Delhi, 110085, India
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Varanasi, 221005, India
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Florence, 50134, Italy
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Milan, 20133, Italy
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Milan, 20162, Italy
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Padova, 35128, Italy
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Pisa, 56126, Italy
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Rozzano, 20089, Italy
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Tricase, Lecce, 73039, Italy
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Hiroshima, 734-8551, Japan
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Kashiwa, 227-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Mitaka-shi, 181-8611, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Osaka, 541-8567, Japan
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Sendai, 980-8574, Japan
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Suita-shi, 565-0871, Japan
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Toyama, 930-0194, Japan
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Ube, 755-8505, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 241-8515, Japan
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Oslo, 0379, Norway
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Bydgoszcz, 85-796, Poland
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Krakow, 31-501, Poland
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Lublin, 20-080, Poland
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Przemyśl, 37-700, Poland
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Warsaw, 02-034, Poland
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29011, Spain
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Pamplona, 31005, Spain
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Santander, 39008, Spain
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 34000, Thailand
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Muang, 50200, Thailand
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Naimuang, 30000, Thailand
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Si Sa Ket, 33000, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Fatih-Istanbul, 34098, Turkey (Türkiye)
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Samsun, 55139, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Edgbaston, B15 2WB, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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London, NW3 2QG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom

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