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Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT03957590

A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

A Phase 3 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 33 sites in China.

Completed

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

Official record
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Trial summary

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tislelizumab, Paclitaxel and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
370 participants
Where
33 sitesChina
Study dates
11 Jun 2019to 31 Mar 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of localized ESCC and suitable for concurrent chemoradiotherapy (cCRT)
  • Measurable and/or non-measurable disease defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function

Who cannot join

  • Indicators of severe malnutrition
  • Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
  • Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
  • Received prior radiotherapy or therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1), PD-L2 or other immune-oncology therapies
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • Changzhou Tumor(Fourth Peoples)Hospital

    Changzhou, Jiangsu, 213000

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510000

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310002

  • 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

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Inner Mongolia Autonomous Region Cancer Hospital

    Hohhot, Inner Mongolia, 010028

  • Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )

    Jieyang, Guangdong, 522000

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • The First Peoples Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).

Being tested
Tislelizumab, Placebo, Paclitaxel, Cisplatin, Radiotherapy
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.

  • TislelizumabDrug

    Also called BGB-A317, Tevimbra

    Administered intravenously (IV)

  • PlaceboDrug

    Placebo to match tislelizumab administered intravenously

  • PaclitaxelDrug

    Administered as 135 mg/m² IV injection

  • CisplatinDrug

    Administered as 25 mg/m² IV injection

  • RadiotherapyRadiation

    Administered at a total dose of 50.4 Gy in 28 fractions

Study groups in NCT03957590
Study groupRoleWhat they receive
Tislelizumab + ChemoradiotherapyExperimentalParticipants received 200 mg tislelizumab administered intravenously (IV) once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy).
Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy
Placebo + ChemoradiotherapyPlacebo comparatorParticipants received placebo IV once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy).
Receives: Drug: Placebo; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method.

    Progressive Disease (PD): 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, and/or unequivocal progression of existing nontarget lesions. or the appearance of one or more new lesions.

    Measured: From randomization to the prespecified primary analysis data cut-off date of 08 January 2025; maximum time on study was 67 months.

Secondary outcomes (6)

  1. Overall Survival (OS)

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

    Measured: From randomization to the prespecified analysis data cut-off date of 08 January 2025; maximum time on study was 67 months.

  2. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oesophageal Cancer Module (OES18) Dysphagia, Reflux, Pain, and Eating Scales

    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 (saliva swallowing, 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 and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems.

    Measured: Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days)

  3. Change From Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, and Fatigue Scores

    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 into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life.

    Measured: Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days)

  4. Overall Response Rate (ORR)

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

    Tumor assessments were made using computed tomography (CT) scans or using magnetic resonance imaging (MRI).

    CR: Disappearance of all target lesions and non-target lesions, no new lesions, and normalization of tumor marker level. All lymph nodes must be nonpathological in size (<10 mm short axis).

    PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and/or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

    Measured: Tumor assessments occurred every 9 weeks for the first 54 weeks, and every 12 weeks during the next 2 years and every 24 weeks thereafter until radiographic disease progression or death; up to 67 months

  5. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the BIRC per RECIST v1.1, or death from any cause, whichever occurs first. DOR was estimated using the Kaplan-Meier method.

    Measured: Up to 67 months

  6. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (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 a study treatment, whether considered related to study treatment or not. A TEAE is an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment and up to 30 days following study treatment discontinuation or initiation of new anticancer therapy, whichever occurred first.

    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:

    • 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 to 30 days after last dose, maximum time on treatment was 57.5 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 May 2019
  2. Study start11 Jun 2019
  3. Primary completion8 Jan 2025
  4. Study completion31 Mar 2025

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03957590
Sponsor's protocol ID
BGB-A317-311
Other IDs
CTR20190198
Status last verified
Mar 2026
First submitted
16 May 2019
Last updated
13 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
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

  • Yu R, Wang W, Li T, Li J, Zhao K, Wang W, Liang L, Wu H, Ai T, Huang W, Li L, Yu W, Wei C, Wang Y, Shen W, Xiao Z. RATIONALE 311: tislelizumab plus concurrent chemoradiotherapy for localized esophageal squamous cell carcinoma. Future Oncol. 2021 Nov;17(31):4081-4089. doi: 10.2217/fon-2021-0632. Epub 2021 Jul 16.

    PubMed 34269067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC), run by BeiGene at 33 sites in China.

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 6 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China. 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?

Yes. Results are posted in the registry (first posted 13 Apr 2026). 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?

Progression-free Survival (PFS) (time frame: From randomization to the prespecified primary analysis data cut-off date of 08 January 2025; maximum time on study was 67 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 NCT03957590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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