Advanced Esophageal Squamous Cell CancerPhase 2NCT05323890
Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.
A Phase 2 study testing Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy in people with Advanced Esophageal Squamous Cell Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Cell Cancer
- What is being tested?
- Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 20 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-75
- Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
- Eastern Cooperative Oncology Group (ECOG) status 0-1
- Signed written informed consent prior to the implementation of any trial-related rocedures
- Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN
Who cannot join
- Patients diagnosed with any other malignant tumor
- Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
- Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
- Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
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- A history of interstitial lung disease or non-infectious pneumonia
- Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
- Patients who have received allogeneic stem cell or solid organ transplantation
- Women during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Meng Xue, Ph.D, M.D, 17653115602, mengxuesdzl@163.com
About this study
Official title: Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study
This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.
- Conditions
- Advanced Esophageal Squamous Cell Cancer
- Being tested
- Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab Combined With Neoadjuvant Radiotherapy and ChemotherapyDrug
Also called Anti-PD-1 Therapy
Patients received tislelizumab at a fixed dose of 200 mg every three weeks (q3w, 21 days) for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab arm | Experimental | Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks) Receives: Drug: Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
No more than 10% of tumor cells were found in neoadjuvant surgical specimens.
Measured: From date of surgery to 14 days later
Pathologic complete response rate
Pathologic complete response rate
Measured: From date of surgery to 14 days later
Secondary outcomes (2)
Disease free survival
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
Measured: 24 months
Incidence of Treatment-related Adverse Events
Number and percentage of cases of all adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start20 Apr 2022
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Esophageal Squamous Cell CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Meng, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323890
- Sponsor's protocol ID
- Shandong CHI
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang J, Ma L, Zhao X, Jin P, Meng X, Du W, Wu Z, Jiao W, Yang W. 18F-FDG PET/CT metabolic parameter to predict pathological complete response and survival after neoadjuvant immunotherapy plus chemoradiotherapy in resectable esophageal squamous cell carcinoma. Cancer Imaging. 2026 Aug 31;26(1):131. doi: 10.1186/s40644-026-01118-5.
PubMed 42754907
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT05323890
- Acronym / sponsor ID
- Shandong CHI
- Conditions
- Advanced Esophageal Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab arm | Experimental | Drug: Tislelizumab Combined With Neoadjuvant Radiotherapy and ChemotherapyRadiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75
- Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
- Eastern Cooperative Oncology Group (ECOG) status 0-1
- Signed written informed consent prior to the implementation of any trial-related rocedures
- Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN
Key exclusion criteria (11 listed)
- Patients diagnosed with any other malignant tumor
- Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
- Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
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 |
|---|---|---|
| Tislelizumab Combined With Neoadjuvant Radiotherapy and ChemotherapyAlso: Anti-PD-1 TherapyPatients received tislelizumab at a fixed dose of 200 mg every three weeks (q3w, 21 days) for 2 cycles. | Drug | Tislelizumab arm |
Primary outcome
Major Pathological Response Rate
Time frame: From date of surgery to 14 days later
No more than 10% of tumor cells were found in neoadjuvant surgical specimens.
Pathologic complete response rate
Time frame: From date of surgery to 14 days later
Pathologic complete response rate
2 secondary outcomes
Disease free survival
Time frame: 24 months
Incidence of Treatment-related Adverse Events
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 42754907Yang J, Ma L, Zhao X, Jin P, Meng X, Du W, Wu Z, Jiao W, Yang W. 18F-FDG PET/CT metabolic parameter to predict pathological complete response and survival after neoadjuvant immunotherapy plus chemoradiotherapy in resectable esophageal squamous cell carcinoma. Cancer Imaging. 2026 Aug 31;26(1):131. doi: 10.1186/s40644-026-01118-5.
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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.
1 site 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 Combined With Neoadjuvant Radiotherapy and Chemotherapy in people with Advanced Esophageal Squamous Cell Cancer, run by Shandong Cancer Hospital and Institute at 1 site 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 11 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Meng, Ph.D, M.D (17653115602, mengxuesdzl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: From date of surgery to 14 days later). The study lists 2 primary outcomes in all. 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 NCT05323890, 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 14 Mar 2023.