Esophagus CancerPhase 2NCT07046221
Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery
A Phase 2 study testing Tislelizumab, Albumin-Bound Paclitaxel and cis-platinum in people with Esophagus Cancer, run by Fujian Cancer Hospital.
Trial summary
To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Tislelizumab, Albumin-Bound Paclitaxel and cis-platinum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Aug 2030
- Phase
- Phase 2
- 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
Who may be able to join
- The subjects were included in this study and signed the informed consent form.
- Male or female patients aged between 18 and 75 years old;
- Patients diagnosed with esophageal squamous cell carcinoma by histopathology;
- According to the 8th edition of the AJCC Esophageal cancer TNM staging system, it is located in cT2N+ or cT3-4aNanyM0 (confirmed by enhanced CT/MRI of the chest and abdomen), and the lesion is located in the thoracic segment.
- ECOG score: 0-1.
- The main organs function normally, that is, they meet the following standards:
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- Blood routine (no blood transfusion was performed within 14 days before treatment, no granulocyte colony-stimulating factor [G-CSF] was used, and no other drugs were used for correction);
- The absolute neutrophil count (ANC) was ≥1.5×109/L;
- Hemoglobin (HB) ≥9.0 g/dL;
- Platelet count (PLT) ≥100×109/L;
- Blood biochemistry
- Creatinine clearance rate ≥60 mL/min;
- Total bilirubin (TBIL) ≤ 1.5×ULN;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
- The expected survival period is ≥3 months;
- Female subjects with reproductive capacity and male subjects whose partners are of childbearing age need to adopt a medically approved contraceptive measure during the study treatment period and for at least 3 months after the last treatment
Who cannot join
- There are clinically uncontrolled pleural effusions, pericardial effusions or ascites that require repeated drainage or medical intervention (within 2 weeks before randomization);
- It is known that there is intolerance or resistance to the chemotherapy specified in the trial protocol;
- Have received any other ESCC anti-tumor treatments (e.g., targeted treatments for PD-1, PD-L1, PD-L2, or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);
- Patients with active autoimmune diseases or a history of autoimmune diseases that may recur, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Have a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.
- Before enrollment, there was a severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibacterial, antifungal or antiviral treatment;
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- A known history of HIV infection;
- Having suffered from other malignant tumors within the past five years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix);
- Have received live vaccines within 28 days before enrollment;
- Participated in other therapeutic clinical trials within 4 weeks;
- Those that the researchers consider unsuitable for inclusion.
- Distant metastasis exists (except for supraclavicular lymph nodes).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery: A Prospective, Open-label, Multicenter Clinical Study
To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group
- Conditions
- Esophagus Cancer
- Being tested
- Tislelizumab, Albumin-Bound Paclitaxel, cis-platinum, Surgery, Radiation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
200mg，d1，q3w，1years
Albumin-Bound PaclitaxelDrug
125mg/m2，d1，d8，q3w，2cycles
cis-platinumDrug
75mg/m2，d1，q3w，2cycles
SurgeryProcedure or surgery
Radical resection of esophageal cancer
RadiationRadiation
50.5Gy/28f
NedaplatinDrug
80-100mg/m2，d1，q3w，2cycles
CarboplatinDrug
AUC=5，d1，q3w，2cycles
| Study group | Role | What they receive |
|---|---|---|
| CRT+Tislelizumab | Experimental | RT：50.5Gy/28f albumin-bound paclitaxel：125mg/m2，d1，d8，q3w，2cycles cis-platinum：75mg/m2，d1，q3w，2cycles/carboplatin：AUC=5，d1，q3w，2 cycles/Nedaplatin：80-100mg/m2，d1，q3w，2 cycles Tislelizumab: 200mg，d1，q3w，1years Receives: Drug: Tislelizumab; Drug: Albumin-Bound Paclitaxel; Drug: cis-platinum; Radiation: Radiation; Drug: Nedaplatin; Drug: Carboplatin |
| surgery+Tislelizumab | Experimental | Radical resection of esophageal cancer Tislelizumab: 200mg，d1，q3w，1years Receives: Drug: Tislelizumab; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate of 2 years
The proportion of patients who were still alive from the start of randomization (or the start of treatment in a single-arm trial) to 2 years
Measured: 2 years
Secondary outcomes (1)
objective response rate
According to the recognized response evaluation criteria (such as recist Version 1.1 for Solid tumors), the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time limit requirements
Measured: every 2 weeks until 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046221
- Sponsor's protocol ID
- EC-01
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery: A Prospective, Open-label, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07046221
- Acronym / sponsor ID
- EC-01
- Conditions
- Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 1 Jul 2025 (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.
To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT+Tislelizumab | Experimental | Drug: Tislelizumab, Drug: Albumin-Bound Paclitaxel, Drug: cis-platinum, Radiation: Radiation, Drug: Nedaplatin, Drug: CarboplatinRT：50.5Gy/28f albumin-bound paclitaxel：125mg/m2，d1，d8，q3w，2cycles cis-platinum：75mg/m2，d1，q3w，2cycles/carboplatin：AUC=5，d1，q3w，2 cycles/Nedaplatin：80-100mg/m2，d1，q3w，2 cycles Tislelizumab: 200mg，d1，q3w，1years |
| surgery+Tislelizumab | Experimental | Drug: Tislelizumab, Procedure: SurgeryRadical resection of esophageal cancer Tislelizumab: 200mg，d1，q3w，1years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subjects were included in this study and signed the informed consent form.
- Male or female patients aged between 18 and 75 years old;
- Patients diagnosed with esophageal squamous cell carcinoma by histopathology;
- According to the 8th edition of the AJCC Esophageal cancer TNM staging system, it is located in cT2N+ or cT3-4aNanyM0 (confirmed by enhanced CT/MRI of the chest and abdomen), and the lesion is located in the thoracic segment.
- ECOG score: 0-1.
Key exclusion criteria (12 listed)
- There are clinically uncontrolled pleural effusions, pericardial effusions or ascites that require repeated drainage or medical intervention (within 2 weeks before randomization);
- It is known that there is intolerance or resistance to the chemotherapy specified in the trial protocol;
- Have received any other ESCC anti-tumor treatments (e.g., targeted treatments for PD-1, PD-L1, PD-L2, or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);
- Patients with active autoimmune diseases or a history of autoimmune diseases that may recur, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Have a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.
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 |
|---|---|---|
| Tislelizumab200mg，d1，q3w，1years | Drug | CRT+Tislelizumab, surgery+Tislelizumab |
| Albumin-Bound Paclitaxel125mg/m2，d1，d8，q3w，2cycles | Drug | CRT+Tislelizumab |
| cis-platinum75mg/m2，d1，q3w，2cycles | Drug | CRT+Tislelizumab |
| SurgeryRadical resection of esophageal cancer | Procedure or surgery | surgery+Tislelizumab |
| Radiation50.5Gy/28f | Radiation | CRT+Tislelizumab |
| Nedaplatin80-100mg/m2，d1，q3w，2cycles | Drug | CRT+Tislelizumab |
| CarboplatinAUC=5，d1，q3w，2cycles | Drug | CRT+Tislelizumab |
Primary outcome
Overall survival rate of 2 years
Time frame: 2 years
The proportion of patients who were still alive from the start of randomization (or the start of treatment in a single-arm trial) to 2 years
1 secondary outcome
objective response rate
Time frame: every 2 weeks until 3 years
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 20 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Albumin-Bound Paclitaxel and cis-platinum in people with Esophagus Cancer, run by Fujian Cancer Hospital.
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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Chen jun qiang, bachelor (13705036281 ext. 86, junqiangc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate of 2 years (time frame: 2 years). 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 20 Jul 2025.