Resectable Esophageal Squamous Cell CarcinomaPhase 2RATIONALE-213NCT04974047
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Resectable Esophageal Squamous Cell Carcinoma, run by BeiGene at 8 sites in China.
Trial summary
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- Tislelizumab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesChina
- Study dates
- 17 Aug 2021to 25 Oct 2024
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
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- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Anhui Provincial Hospital
Hefei, Anhui, 230000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tangdu Hospital
Xi'an, Shaanxi, 710038
About this study
Official title: 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
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
Read the detailed description
This study enrolled participants with esophageal squamous cell carcinoma who were eligible to have their tumor removed by surgery (also called surgical resection). The treatment phase of the study included the following:
- Induction therapy, in which participants received 1 cycle of chemotherapy;
- Neoadjuvant therapy (neoadjuvant refers to treatment that occurs before surgery, which can make the tumor easier to remove). In this study participants received neoadjuvant therapy based on their response to induction therapy. Response to induction therapy was assessed using the maximum standardized uptake value (SUVmax) measured using a Positron Emission Tomography (PET) scan. The SUV number refers to the level of brightness on the PET scan which reflects metabolic activity; increased metabolic activity can indicate cancerous growth.
- Participants with a decrease in SUVmax of 35% or more after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy.
- Participants with a decrease in SUVmax less than 35% after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy and radiotherapy.
- Surgery to remove the remaining tumor (resection) was to occur 4-6 weeks after completion of neoadjuvant treatment.
After surgery participants were followed until death, lost to follow-up, withdrawal of consent, or until the study was completed
- Being tested
- Tislelizumab, Paclitaxel, Cisplatin, 5-fluorouracil, Radiotherapy
- Keywords
- Tislelizumab, PET, Chemotherapy, Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Administered intravenously on Day 1 of each 21-Day Cycle.
PaclitaxelDrug
135 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle.
CisplatinDrug
80 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle.
5-fluorouracilDrug
1000 mg/m^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle.
RadiotherapyRadiation
40 grays/20 fractions
Surgical resectionProcedure or surgery
Performed as indicated in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Responder) | Experimental | Participants 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. Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgical resection |
| Cohort B (Non-responder) | Experimental | Participants 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. Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-fluorouracil; Radiation: Radiotherapy; Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins.
Measured: 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
The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Measured: 1 year and 3 years after surgery
1-year/3-year Event-free Survival (EFS) Rate
The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Measured: 1 year and 3 years after first dose date
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: ORR was assessed prior to surgery, Day 71 to 86
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start17 Aug 2021
- Primary completion17 Apr 2023
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Resectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974047
- Sponsor's protocol ID
- BGB-A317-213
- Other IDs
- CTR20211753
- Acronym
- RATIONALE-213
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2021
- Last updated
- 1 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04974047
- Acronym / sponsor ID
- RATIONALE-213 / BGB-A317-213
- Keywords
- Tislelizumab, PET, Chemotherapy, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 1 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
Detailed description
This study enrolled participants with esophageal squamous cell carcinoma who were eligible to have their tumor removed by surgery (also called surgical resection). The treatment phase of the study included the following:
- Induction therapy, in which participants received 1 cycle of chemotherapy;
- Neoadjuvant therapy (neoadjuvant refers to treatment that occurs before surgery, which can make the tumor easier to remove). In this study participants received neoadjuvant therapy based on their response to induction therapy. Response to induction therapy was assessed using the maximum standardized uptake value (SUVmax) measured using a Positron Emission Tomography (PET) scan. The SUV number refers to the level of brightness on the PET scan which reflects metabolic activity; increased metabolic activity can indicate cancerous growth.
- Participants with a decrease in SUVmax of 35% or more after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy.
- Participants with a decrease in SUVmax less than 35% after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy and radiotherapy.
- Surgery to remove the remaining tumor (resection) was to occur 4-6 weeks after completion of neoadjuvant treatment.
After surgery participants were followed until death, lost to follow-up, withdrawal of consent, or until the study was completed
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Responder) | Experimental | Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Procedure: Surgical resectionParticipants 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) | Experimental | Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Drug: 5-fluorouracil, Radiation: Radiotherapy, Procedure: Surgical resectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: BGB-A317Administered intravenously on Day 1 of each 21-Day Cycle. | Drug | Cohort A (Responder), Cohort B (Non-responder) |
| Paclitaxel135 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle. | Drug | Cohort A (Responder), Cohort B (Non-responder) |
| Cisplatin80 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle. | Drug | Cohort A (Responder), Cohort B (Non-responder) |
| 5-fluorouracil1000 mg/m^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle. | Drug | Cohort B (Non-responder) |
| Radiotherapy40 grays/20 fractions | Radiation | Cohort B (Non-responder) |
| Surgical resectionPerformed as indicated in the treatment arm. | Procedure or surgery | Cohort A (Responder), Cohort B (Non-responder) |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
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.
5 secondary outcomes
R0 Resection Rate
Time frame: 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
Time frame: 1 year and 3 years after surgery
1-year/3-year Event-free Survival (EFS) Rate
Time frame: 1 year and 3 years after first dose date
Objective Response Rate (ORR)
Time frame: ORR was assessed prior to surgery, Day 71 to 86
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Resectable Esophageal Squamous Cell Carcinoma, run by BeiGene at 8 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 5 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Dec 2025). 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?
Pathological Complete Response (pCR) Rate (time frame: pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.