Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
RATIONALE-213
A Phase 2, Multicenter, Open-label, 2-Cohort Study to Investigate the Efficacy and Safety of PET Guided Neoadjuvant Treatment With Tislelizumab (BGB-A317) Plus Chemotherapy/Chemoradiotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
2 other identifiers
interventional
70
1 country
8
Brief Summary
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
August 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedResults Posted
Study results publicly available
December 1, 2025
CompletedDecember 1, 2025
November 1, 2025
1.7 years
July 3, 2021
November 14, 2025
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Complete Response (pCR) Rate
The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.
pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
Secondary Outcomes (5)
R0 Resection Rate
Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
1-year/3-year Disease-free Survival (DFS) Rate
1 year and 3 years after surgery
1-year/3-year Event-free Survival (EFS) Rate
1 year and 3 years after first dose date
Objective Response Rate (ORR)
ORR was assessed prior to surgery, Day 71 to 86
Number Of Participants Experiencing Treatment-Emergent Adverse Events
From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months.
Study Arms (2)
Cohort A (Responder)
EXPERIMENTALParticipants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
Cohort B (Non-responder)
EXPERIMENTALParticipants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
Interventions
Administered intravenously on Day 1 of each 21-Day Cycle.
135 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
80 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
1000 mg/m\^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle.
Performed as indicated in the treatment arm.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition).
- Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent.
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose.
You may not qualify if:
- Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
- Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways.
- History of fistula due to primary tumor invasion.
- Participants with high risk of fistula or sign of perforation evaluated by investigator.
- Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
- \* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- \* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
- With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.
- Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (8)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2021
First Posted
July 23, 2021
Study Start
August 17, 2021
Primary Completion
April 17, 2023
Study Completion
October 25, 2024
Last Updated
December 1, 2025
Results First Posted
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.