Locally Advanced Esophageal Squamous Cell CarcinomaNCT07549100
Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
An observational study of Locally Advanced Esophageal Squamous Cell Carcinoma, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks [Q3W]) plus cisplatin (75… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Tislelizumab Plus Chemotherapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Who may be able to join
- Written informed consent is obtained prior to any study-related procedures.
- Age 18 to 75 years, inclusive; both male and female patients are eligible.
- Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:
- T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases.
- No evidence of distant metastasis.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy of ≥6 months.
- Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment):
- Hematologic function: absolute neutrophil count (ANC) ≥1,500/mm³; platelet count ≥100,000/mm³; hemoglobin ≥9 g/dL (5.6 mmol/L).
- Renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min.
- Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN.
- For women of childbearing potential: must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use a medically acceptable method of contraception (e.g., intrauterine device, oral contraceptives, or barrier methods) during the study treatment period and for at least 3 months after the last dose.
- For men with partners of childbearing potential: must agree to use a medically acceptable method of contraception during the study treatment period and for at least 3 months after the last dose.
- Willingness to participate in the study, good compliance, and ability to adhere to study procedures, including safety and survival follow-up.
Who cannot join
- Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.
- Evidence of distant metastasis confirmed by imaging.
- History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.
- Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.
- Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible.
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- Patients with asthma requiring bronchodilator therapy are not eligible.
- Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- Clinically significant ascites or pleural effusion requiring therapeutic drainage.
- Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
- New York Heart Association (NYHA) class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year prior to enrollment; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Coagulation abnormalities, defined as: prothrombin time (PT) >16 seconds, activated partial thromboplastin time (APTT) >43 seconds, thrombin time (TT) >21 seconds, or fibrinogen (Fbg) >2 g/L; or presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.
- Presence of gastrointestinal conditions associated with a high risk of bleeding or perforation within 3 months prior to enrollment, including but not limited to esophageal varices, active gastric or duodenal ulcers, ulcerative colitis, portal hypertension, or unresected tumors with active bleeding; or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
ALei Feng, +8613402214659, 370100668@qq.com
About this study
Official title: Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks [Q3W]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.
Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
- Being tested
- Tislelizumab Plus Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab Plus ChemotherapyDrug
albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks [Q3W]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab Plus Chemotherapy | Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma Receives: Drug: Tislelizumab Plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion Surgery Rate
Defined as the proportion of patients with initially unresectable locally advanced esophageal squamous cell carcinoma who become eligible for curative-intent surgical resection after study treatment, as determined by multidisciplinary team (MDT) assessment.
Measured: Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles
Secondary outcomes (3)
Pathological Complete Response (pCR) Rate
pCR is defined as the absence of residual viable tumor cells in both the primary tumor and regional lymph nodes (ypT0N0)
Measured: At the time of surgery, approximately 8-16 weeks after initiation of study treatment.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of complete response (CR) or partial response (PR).
Measured: From baseline to completion of 2-4 cycles of treatment (approximately 6-12 weeks), at post-treatment tumor assessment.
Incidence of Treatment-Related Adverse Events (TRAEs)
TRAEs are defined as adverse events considered by investigators to be related to study treatment.
Measured: From the first dose of study treatment up to 30 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 May 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yang Zhe, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549100
- Sponsor's protocol ID
- SWYX:NO.2023-1029
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07549100
- Acronym / sponsor ID
- SWYX:NO.2023-1029
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Apr 2026 (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 is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks [Q3W]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.
Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab Plus Chemotherapy | – | Drug: Tislelizumab Plus ChemotherapyUnresectable Locally Advanced Esophageal Squamous Cell Carcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Key inclusion criteria (15 listed)
- Written informed consent is obtained prior to any study-related procedures.
- Age 18 to 75 years, inclusive; both male and female patients are eligible.
- Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:
- T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases.
- No evidence of distant metastasis.
Key exclusion criteria (13 listed)
- Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.
- Evidence of distant metastasis confirmed by imaging.
- History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.
- Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.
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 Plus Chemotherapyalbumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks [Q3W]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles | Drug | Tislelizumab Plus Chemotherapy |
Primary outcome
Conversion Surgery Rate
Time frame: Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles
Defined as the proportion of patients with initially unresectable locally advanced esophageal squamous cell carcinoma who become eligible for curative-intent surgical resection after study treatment, as determined by multidisciplinary team (MDT) assessment.
3 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery, approximately 8-16 weeks after initiation of study treatment.
Objective Response Rate (ORR)
Time frame: From baseline to completion of 2-4 cycles of treatment (approximately 6-12 weeks), at post-treatment tumor assessment.
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From the first dose of study treatment up to 30 days after the last dose of study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Esophageal Squamous Cell Carcinoma, run by Shandong Provincial Hospital 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 15 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: looking for participants now, as of the sponsor's last update on 23 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALei Feng (+8613402214659, 370100668@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion Surgery Rate (time frame: Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles). 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 23 Apr 2026.