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Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT03430843

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

A Phase 3 study testing Tislelizumab, Paclitaxel and Docetaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 104 sites in 11 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 was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
104 sitesin 11 countries
Study dates
26 Jan 2018to 28 Dec 2022
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

  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
  • Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
  • At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Who cannot join

  • Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
  • History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
  • Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  • Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
  • Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
Show all 13Show fewer
  • Active brain or leptomeningeal metastasis.
  • Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
  • Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
  • Known history of Human Immunodeficiency Virus (HIV)
  • Has cardiovascular risk factors
  • Pregnant or breastfeeding woman.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

104 sites in 11 countries.

104 sites in 11 countries

China38 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • 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 Sixth Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510655

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Huaian Second Peoples Hospital

    Huaian, Jiangsu, 223002

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Nantong Tumor Hospital Branch South

    Nantong, Jiangsu, 226000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Shanxi Provincial Peoples Hospital

    Taiyuan, Shanxi, 030012

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • 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

Japan17 sites

  • Akita University Hospital

    Akitashi, Akita, 010-8543

  • National Cancer Center Hospital

    Chuoku, Tokyo, 104-0045

  • Nho Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center

    Kitaadachigun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kochi Health Sciences Center

    Kochi, 781-8555

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

  • Kyoto University Hospital

    Kyoto, 6068507

  • Nho Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Osaka International Cancer Institute

    Osakashi, Osaka, 541-8567

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Osaka University Hospital

    Suitashi, Osaka, 565-0871

  • Shizuoka Cancer Center

    Suntogun, Shizuoka, 411-8777

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsukishi, Osaka, 569-8686

  • St Marianna University School of Medicine Hospital

    Yokohama, Kanagawa, 216-8511

Other trials in Japan

France10 sites

  • Chru de Brest Hospital Morvan

    Brest, 29200

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Chu Besancon Hopital Jean Minjoz

    Doubs, 25030

  • Centre Oscar Lambret

    Lille, 59000

  • Hopital Prive Jean Mermoz

    Lyon, 69008

  • Icm Val Daurelle

    Montpellier, 34090

  • Chu Bordeaux Hopital Haut Leveque

    Pessac, 33600

  • Chu de Poitiers Site de La Mileterie

    Poitiers, 86000

  • Ico Site Rene Gauducheau

    SaintHerblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain8 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Institut Catala Doncologia

    Barcelona, 08908

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario de Octubre

    Madrid, 28041

  • Hospital Universitario Hm Madrid Sanchinarro

    Madrid, 28050

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do, 58128

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi, 08308

Other trials in South Korea

United Kingdom6 sites

  • The Christie Hospital

    Greater Manchester, M20 4BX

  • Guys and St Thomas Hospital Nhs Foundation Trust

    London, SE1 9RT

  • Sarah Cannon Research Institute Uk

    London, W1G 6AD

  • St Marys Hospital Imperial College Healthcare Nhs Trust

    London, W2 1NY

  • Mount Vernon Hospital (Mount Vernon Cancer Center)

    Northwood, HA6 2RN

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Italy5 sites

  • Ospedale Di Faenza

    Faenza, 48018

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, 56126

  • Ao Citta Della Salute E Della Scienza Di Torino Presidio O

    Torino, 10126

Other trials in Italy

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Chi Mei Hospital Liouying

    Tainan, 736

  • National Taiwan University Hospital East Campus

    Taipei, 100225

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium4 sites

  • Imelda Ziekenhuis Bonheiden

    Bonheiden, 2820

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Uz Antwerpen

    Edegem, 2650

  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

Germany3 sites

  • Charite Universitatsmedizin Berlin

    Berlin, 13353

  • Universitares Krebszentrum Leipzig

    Leipzig, 04103

  • Klinikum Johannes Gutenberg Universitaet Mainz

    Mainz, 55131

Other trials in Germany

United States2 sites

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

Other trials in United States

About this study

Official title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Keywords
Unresectable, metastatic, second-line, squamous, esophagus, chemotherapy, paclitaxel, docetaxel, irinotecan
Medical subject headings
Esophageal Squamous Cell Carcinoma, Neoplasm Metastasis

What participants receive

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

  • TislelizumabDrug

    Also called BGB-A317

    200 mg administered intravenously (IV)

  • PaclitaxelDrug

    135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care

  • DocetaxelDrug

    75 mg/m^2 administered IV or 70 mg/m^2 IV in Japan

  • IrinotecanDrug

    125 mg/m^2 administered IV

Study groups in NCT03430843
Study groupRoleWhat they receive
TislelizumabExperimentalTislelizumab on Day 1, given every 21 days
Receives: Drug: Tislelizumab
Investigator chosen chemotherapy (ICC)Active comparatorPaclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days
Receives: Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan

What is being measured

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

  1. Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set

    OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants

    Measured: Approximately 2 years and 10 months from date of first randomization

Secondary outcomes (14)

  1. Overall Survival (OS) in the PDL-1 Positive Analysis Set

    OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  2. Objective Response Rate (ORR) in the ITT Analysis Set

    ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  3. Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets

    ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  4. Progression-free Survival (PFS) in the ITT Analysis Set

    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  5. Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set

    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  6. Duration of Response (DOR) in the ITT Analysis Set

    DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  7. Duration of Response (DOR) in the PDL-1 Positive Analysis Set.

    DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

    Measured: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

  8. Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set

    Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes

    Measured: Baseline to Cycle 6 (21 days per cycle)

  9. HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set

    Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes

    Measured: Baseline to Cycle 6 (21 days per cycle)

  10. HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set

    Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

    Measured: Baseline to Cycle 6 (21 days per cycle)

  11. HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.

    Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

    Measured: Baseline to Cycle 6 (21 days per cycle)

  12. HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set

    Mean change from baseline in EQ-5D-5L visual acuity score (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 to Cycle 6 (21 days per cycle)

  13. HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set

    Mean change from baseline in EQ-5D-5L visual acuity score (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 to Cycle 6 (21 days per cycle)

  14. Number of Participants Experiencing Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs

    Measured: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

Timeline

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

  1. First posted13 Feb 2018
  2. Study start26 Jan 2018
  3. Primary completion1 Dec 2020
  4. Study completion28 Dec 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430843
Sponsor's protocol ID
BGB-A317-302
Other IDs
2017-003699-30, CTR20171026, 2017
Status last verified
Oct 2024
First submitted
29 Jan 2018
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.

    PubMed 35442766

  • Ajani JA, Wang K, Nikolaidis GF, Coaquira Castro J, Augusto Novis de Figueiredo M, Sun JM, Soulanis K, Tasoulas A, Zhan L. Comparative Efficacy and Safety of Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma: Systematic Literature Review and Simulated Treatment Comparisons. Adv Ther. 2026 Feb;43(2):567-582. doi: 10.1007/s12325-025-03410-5. Epub 2025 Dec 3.

    PubMed 41335329

  • 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

  • Lu Z, Du W, Jiao X, Wang Y, Shi J, Shi Y, Shu Y, Niu Z, Hara H, Wu J, Hsu CH, Van Cutsem E, Brock MV, Zhang Z, Ding N, Zhang Y, Shen Z, Shen L. NOTCH1 Mutation and Survival Analysis of Tislelizumab in Advanced or Metastatic Esophageal Squamous Cell Carcinoma: A Biomarker Analysis From the Randomized, Phase III, RATIONALE-302 Trial. J Clin Oncol. 2025 Jun;43(16):1898-1909. doi: 10.1200/JCO-24-01818. Epub 2025 Apr 3.

    PubMed 40179324

  • He Q, Shi X, Yan J, Wu M, Gu C, Yu X. Circulating tumor DNA serial monitoring of relapse and responses to tislelizumab immunotherapy as second-line monotherapy for metastatic esophageal squamous cell carcinoma: A prospective study. Mol Clin Oncol. 2024 Feb 9;20(4):29. doi: 10.3892/mco.2024.2727. eCollection 2024 Apr.

    PubMed 38414510

  • Wang LL, Xie YX, Liu Y. Clinical efficacy and adverse reactions analysis of PD-1/PD-L1 inhibitors in advanced esophageal squamous cell carcinoma. Eur Rev Med Pharmacol Sci. 2024 Jan;28(2):659-667. doi: 10.26355/eurrev_202401_35062.

    PubMed 38305608

  • Hara H, Satoh T, Kojima T, Tsushima T, Sunakawa Y, Okada M, Ding N, Wu H, Li L, Yu T, Barnes G, Kato K. Second-line tislelizumab versus chemotherapy in Japanese patients with advanced or metastatic esophageal squamous cell carcinoma: subgroup analysis from RATIONALE-302. Esophagus. 2024 Apr;21(2):102-110. doi: 10.1007/s10388-023-01040-w. Epub 2024 Jan 19.

    PubMed 38240916

  • Kim SB, Van Cutsem E, Ajani J, Shen L, Barnes G, Ding N, Tao A, Xia T, Zhan L, Kato K. Tislelizumab in advanced/metastatic esophageal squamous cell carcinoma: health-related quality of life in Asian patients. Curr Med Res Opin. 2024 Jan;40(1):69-75. doi: 10.1080/03007995.2023.2270894. Epub 2024 Jan 3.

    PubMed 37846080

  • Van Cutsem E, Kato K, Ajani J, Shen L, Xia T, Ding N, Zhan L, Barnes G, Kim SB. Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life. ESMO Open. 2022 Aug;7(4):100517. doi: 10.1016/j.esmoop.2022.100517. Epub 2022 Jul 1.

    PubMed 35785595

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Paclitaxel and Docetaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 104 sites in 11 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 4 inclusion and 13 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in China, Japan, France, Spain, South Korea and 6 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 29 Dec 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) in the Intent-to-Treat (ITT) Analysis Set (time frame: Approximately 2 years and 10 months from date of first randomization). 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 NCT03430843, which also lists 9 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 26 Oct 2024.

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