AzTrials
AzTrials

Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT03783442

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

A Phase 3 study testing Cisplatin, Oxaliplatin and Fluorouracil (5-FU) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 124 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Oxaliplatin and Fluorouracil (5-FU)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
649 participants
Where
124 sitesin 16 countries
Study dates
11 Dec 2018to 22 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Pathologically (histologically) confirmed diagnosis of ESCC
  • Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

Who cannot join

  • Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  • Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  • Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
  • Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
  • Evidence of complete esophageal obstruction not amenable to treatment
Show all 10Show fewer
  • Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
  • Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
  • Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

124 sites in 16 countries.

124 sites in 16 countries

China42 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The Fifth Medical Center of Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510405

  • Guangdong Province Traditional Chinese Medical Hospitsal

    Guangzhou, Guangdong, 510655

  • The Sixth Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510655

  • Hainan General Hospital

    Haikou, Hainan, 570206

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

  • Nantong Tumor Hospital Branch North

    Nantong, Jiangsu, 226000

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Shanxi Provincial Peoples Hospital

    Taiyuan, Shanxi, 030012

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital )

    Wuxi, Jiangsu, 214062

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Japan15 sites

  • Hyogo Cancer Center

    AkashiShi, Hyōgo, 673-0021

  • Akita University Hospital

    Akitashi, Akita, 010-8543

  • Johas Kansai Rosai Hospital

    Amagasakishi, Hyōgo, 660-8511

  • National Cancer Center Hospital

    ChuoKu, Tokyo, 104-0045

  • Nho Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • National Hospital Organization Kyushu Medical Center

    Fukuokacity, Fukuoka, 810-8563

  • Hiroshima University Hospital

    Hiroshima, 734-0037

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center

    Kitaadachigun, Saitama, 362-0806

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • University Hospital, Kyoto Prefectural Univ of Medicine

    KyotoShi, Kyoto, 602-8566

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka International Cancer Institute

    OsakaShi, Osaka, 541-8567

  • The University of Osaka Hospital

    Suitashi, Osaka, 565-0871

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France10 sites

  • Chru de Brest Hopital Cavale Blanche

    Brest, 29200

  • Chu Besancon Hopital Jean Minjoz

    Doubs, 25030

  • Hopital Franco Britannique

    LevalloisPerret, 92300

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Saint Antoine Service Dhepato Gastro Enterologie

    Paris, 75012

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Chu Bordeaux Hopital Haut Leveque

    Pessac, 33600

  • Chu de Poitiers Site de La Mileterie

    Poitiers, 86000

  • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau

    SaintHerblain, 44805

Other trials in France

South Korea10 sites

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do, 13620

  • Keimyung University Dongsan Hospital

    Dalseogu, Daegu Gwang'yeogsi, 42601

  • Smg Snu Boramae Medical Center

    DongjakGu, Seoul Teugbyeolsi, 07061

  • Korea University Guro Hospital

    GuroGu, Seoul Teugbyeolsi, 08308

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do, 58128

  • Gachon University Gil Medical Center

    NamdongGu, Incheon Gwang'yeogsi, 21565

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

  • Samsung Medical Center Hematology Oncology

    Seoul, Seoul Teugbyeolsi, 135-740

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

Other trials in South Korea

Russia7 sites

  • Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Rbih Ivanovo Regional Oncological Dispensary

    Ivanovo, Ivanovo Oblast, 153040

  • State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary

    Kuzmolovsky, Leningradskaya Oblast', 188663

  • Orenburg Regional Clinical Oncology Center

    Orenburg, Orenburg Oblast, 460021

  • Rostov State Medical University

    RostovonDon, Rostov Oblast, 344022

  • Pavlov First Saint Petersburg State Medical University

    SaintPetersburg, Sankt-Peterburg, 197022

  • Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf

    SaintPetersburg, 197758

Other trials in Russia

Spain7 sites

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Institut Catala Doncologia

    Barcelona, 08908

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Belgium6 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Az Sint Jan Brugge

    Bruges, 8000

  • Grand Hopital de Charleroi Site Notre Dame

    Charleroi, 6000

  • UZ GENT

    Ghent, 9000

  • University Hospitals Leuven

    Leuven, 3000

  • Chc Montlegia

    Liège, 4000

Other trials in Belgium

Italy5 sites

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione G Pascale

    Naples, 80131

  • Iov Istituto Oncologico Veneto Irccs

    Padova, 35128

  • Azienda Ospedaliera Universitaria Delle Marche

    Torrette, 60020

Other trials in Italy

Poland4 sites

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200

  • Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie

    Koszalin, 75-581

  • Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Romania4 sites

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

    ClujNapoca, 400015

  • Medisprof Cancer Center

    ClujNapoca, 400641

  • Radiotherapy Center Cluj

    ClujNapoca, 407280

  • Sc Centrul de Oncologie Sf Nectarie Srl

    Craiova, 200347

Other trials in Romania

Taiwan4 sites

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 61363

  • Chi Mei Hospital Liouying

    Liuying Dist, 73657

  • China Medical University Hospital

    North Dist, 404327

  • Chi Mei Medical Center

    Yongkang Dist, 710

Other trials in Taiwan

Germany3 sites

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251

  • Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin

    Heilbronn, 74078

  • Universitares Krebszentrum Leipzig

    Leipzig, 04103

Other trials in Germany

United States2 sites

  • Smilow Cancer Hospital At Yale

    New Haven, Connecticut, 06510-3220

  • Renovatio Clinical

    The Woodlands, Texas, 77380-3476

Other trials in United States

Australia2 sites

  • Coffs Harbour Base Hospital

    Coffs Harbour, New South Wales, 2450

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

Other trials in Australia

United Kingdom2 sites

  • The Christie Hospital

    Greater Manchester, M20 4BX

  • Guys and St Thomas Hospital Nhs Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

Czechia1 site

  • Fakultni Thomayerova Nemocnice

    Prague, 140 59

Other trials in Czechia

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Being tested
Cisplatin, Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Paclitaxel
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • CisplatinDrug

    Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan.

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks.

  • Fluorouracil (5-FU)Drug

    Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle.

  • CapecitabineDrug

    Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle

  • PaclitaxelDrug

    Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks.

  • TislelizumabBiological

    Also called BGB-A317, TEVIMBRA

    Tislelizumab 200 mg administered by intravenous infusion every 3 weeks.

  • PlaceboDrug

    Placebo to match tislelizumab administered by intravenous infusion every 3 weeks.

Study groups in NCT03783442
Study groupRoleWhat they receive
Tislelizumab + ChemotherapyExperimentalParticipants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1).
Receives: Drug: Cisplatin; Drug: Oxaliplatin; Drug: Fluorouracil (5-FU); Drug: Capecitabine; Drug: Paclitaxel; Biological: Tislelizumab
Placebo + ChemotherapyActive comparatorParticipants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1).
Receives: Drug: Cisplatin; Drug: Oxaliplatin; Drug: Fluorouracil (5-FU); Drug: Capecitabine; Drug: Paclitaxel; Drug: Placebo

What is being measured

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

  1. Overall Survival (OS)

    Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

    Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority.

    Measured: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Secondary outcomes (9)

  1. Progression-Free Survival (PFS)

    Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

    Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions.

    Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

    Measured: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen.

    CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022).

    Measured: Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

  3. Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10%

    OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

    Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

    Measured: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

  4. Duration of Response (DOR)

    DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

    Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

    Measured: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

  5. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores

    The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems.

    Measured: Baseline, Cycle 6 (Week 15)

  6. Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales

    The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.

    Measured: Baseline, Cycle 6 (Week 15)

  7. Change From Baseline in EORTC QLQ-C30 Fatigue Scale

    The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.

    Measured: Baseline, Cycle 6 (Week 15)

  8. Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS)

    The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

    Measured: Baseline, Cycle 6 (Week 15)

  9. Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not.

    An SAE is any untoward medical occurrence that, at any dose met any of the following criteria:

    • Resulted in death
    • Was life-threatening
    • Required hospitalization or prolongation of existing hospitalization
    • Resulted in disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was considered a significant medical AE by the Investigator based on medical judgement.

    Measured: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months.

Timeline

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

  1. First posted21 Dec 2018
  2. Study start11 Dec 2018
  3. Primary completion28 Feb 2022
  4. Study completion22 Aug 2024

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
Double blind
Who is masked
Participant, Investigator
Enrolment
649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03783442
Sponsor's protocol ID
BGB-A317-306
Other IDs
2018-000587-28, CTR20181013, JapicCTI-194741, 2018
Status last verified
Jul 2025
First submitted
18 Dec 2018
Last updated
29 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Publications

  • Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.

    PubMed 37080222

  • Yoon HH, Kato K, Raymond E, Hubner R, Shu Y, Pan Y, Park SR, Kojima T, Lin CY, Wyrwicz L, Tougeron D, Ishihara R, Wang K, Peng Y, Xu J. First-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in unresectable advanced/metastatic esophageal squamous cell carcinoma: minimum 3-year survival follow-up of a randomized phase 3 trial (RATIONALE-306). Nat Commun. 2026 Sep 3;17(1):10499. doi: 10.1038/s41467-026-77327-0.

    PubMed 42834033

  • Moehler M, Yoon HH, Wagner DC, Yang S, Shi J, Zhang Y, Hu H, La Placa C, Peng Y, Du W, McCampbell A, Xu W, Shen Z, Xu H, Huang R, Kato K. Concordance Between the PD-L1 Tumor Area Positivity Score and Combined Positive Score for Gastric or Esophageal Cancers Treated With Tislelizumab. Mod Pathol. 2025 Sep;38(9):100793. doi: 10.1016/j.modpat.2025.100793. Epub 2025 May 13.

    PubMed 40373876

  • Xu J, Kato K, Hubner R, Park SR, Kojima T, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Wu H, Wang L, Yan S, Shi J, Kadva A, Yoon HH. First-Line Tislelizumab Plus Chemotherapy for Esophageal Squamous Cell Carcinoma with Programmed Death-Ligand 1 Expression >/= 1%: A Retrospective Analysis of RATIONALE-306. Adv Ther. 2025 May;42(5):2269-2284. doi: 10.1007/s12325-025-03115-9. Epub 2025 Mar 13.

    PubMed 40075024

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Oxaliplatin and Fluorouracil (5-FU) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 124 sites in 16 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 2 inclusion and 10 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in China, Japan, France, South Korea, Russia and 11 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?

Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (OS) (time frame: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 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 NCT03783442, which also lists 4 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 29 Jul 2025.

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