Esophagus CancerPhase 2NCT07019181
Tislelizumab Combined With Chemotherapy for the Perioperative Treatment of Esophageal Squamous Carcinoma
A Phase 2 study testing Tislelizumab, albumin-bound paclitaxel and Nedaplatin in people with Esophagus Cancer, run by The First Affiliated Hospital of Xiamen University.
Trial summary
Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy 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 Nedaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 31 Dec 2026
- 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
- Subjects were enrolled in the study and signed an informed consent form.
- Male or female patients between the ages of 18 and 75.
- Patients with esophageal squamous carcinoma diagnosed by histopathology.
- According to the TNM staging system of esophageal cancer in the 8th edition of the AJCC,the disease is in the stage of cT3-4aN0M0 or cT1b-4aN+M0 (confirmed by thoracic and abdominal enhancement CT/MRI), and the lesion is located in the thoracic segment.
- ECOG score: 0-1.
- Normal functioning of major organs, i.e. meeting the following criteria.
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- Blood count (no blood transfusions, granulocyte colony-stimulating factor [G-CSF], or other medications corrected within 14 days prior to treatment); and Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥9.0 g/dL; and Platelet count (PLT) ≥ 100 x 109/L;
- blood biochemistry Creatinine clearance ≥60 mL/min. Total bilirubin (TBIL) ≤ 1.5 x ULN. Albuminous aminotransferase (AST) or albuminous aminotransferase (ALT) levels ≤ 2.5 x ULN;
- Expected survival > 6 months.
- Female subjects of childbearing potential and male subjects with partners of childbearing potential are required to use a medically approved contraceptive method during study treatment and for at least 6 months after the last treatment.
Who cannot join
- The presence of clinically uncontrolled chest that required repeated drainage or medical intervention (within 2 weeks prior to randomization) Hydrocele, pericardial hydrocele or ascites;
- Known intolerance or resistance to chemotherapy specified in the trial protocol;
- Have received any other ESCC anti-tumor therapy (e.g., targeting PD-1, PD-L1, PD-L2) Or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapy);
- Patients who have an active autoimmune disease or have a history of an autoimmune disease but may relapse may have a known abnormality History of body organ transplantation or allogeneic hematopoietic stem cell transplantation;
- A history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, including pulmonary fibrosis, Acute lung disease;
- There were severe chronic or active patients requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment Infection (including tuberculosis infection, etc.);
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- Have a known history of HIV infection;
- The presence of any serious or uncontrolled systemic disease, including but not limited to:
- Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, cerebrovascular accident, or transient ischemic attack, during the 6 months prior to the first dose of the study; Uncontrolled hypertension (i.e., ≥ CTC-AE level 2 hypertension after medication); active pulmonary tuberculosis; those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- Had other malignancies in the past 5 years (cured skin basal cell carcinoma, breast carcinoma in situ and Except primary cervical cancer);
- Had received live vaccine within 28 days prior to enrollment;
- Have participated in other therapeutic clinical trials within 4 weeks;
- And those deemed unsuitable for inclusion by the researchers.
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 the Perioperative Treatment of Esophageal Squamous Carcinoma： Single-arm Clinical Phase II Study
Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy
- Conditions
- Esophagus Cancer
- Being tested
- Tislelizumab, albumin-bound paclitaxel, Nedaplatin
- 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
Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
albumin-bound paclitaxelDrug
albumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks
NedaplatinDrug
Nedaplatin 80mg/m2，day 1 of every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: albumin-bound paclitaxel; Drug: Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Secondary outcomes (2)
Major pathological response rate
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Objective Response Rate
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: At the end of Cycle 2(each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start30 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 The First Affiliated Hospital of Xiamen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019181
- Sponsor's protocol ID
- SL-2024KY088-01
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Chemotherapy for the Perioperative Treatment of Esophageal Squamous Carcinoma： Single-arm Clinical Phase II Study
- ClinicalTrials.gov ID
- NCT07019181
- Acronym / sponsor ID
- SL-2024KY088-01
- Conditions
- Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 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.
Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with chemotherapy | Experimental | Drug: Tislelizumab, Drug: albumin-bound paclitaxel, Drug: Nedaplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects were enrolled in the study and signed an informed consent form.
- Male or female patients between the ages of 18 and 75.
- Patients with esophageal squamous carcinoma diagnosed by histopathology.
- According to the TNM staging system of esophageal cancer in the 8th edition of the AJCC,the disease is in the stage of cT3-4aN0M0 or cT1b-4aN+M0 (confirmed by thoracic and abdominal enhancement CT/MRI), and the lesion is located in the thoracic segment.
- ECOG score: 0-1.
Key exclusion criteria (13 listed)
- The presence of clinically uncontrolled chest that required repeated drainage or medical intervention (within 2 weeks prior to randomization) Hydrocele, pericardial hydrocele or ascites;
- Known intolerance or resistance to chemotherapy specified in the trial protocol;
- Have received any other ESCC anti-tumor therapy (e.g., targeting PD-1, PD-L1, PD-L2) Or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapy);
- Patients who have an active autoimmune disease or have a history of an autoimmune disease but may relapse may have a known abnormality History of body organ transplantation or allogeneic hematopoietic stem cell transplantation;
- A history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, including pulmonary fibrosis, Acute lung disease;
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 |
|---|---|---|
| TislelizumabTislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks | Drug | Tislelizumab combined with chemotherapy |
| albumin-bound paclitaxelalbumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks | Drug | Tislelizumab combined with chemotherapy |
| NedaplatinNedaplatin 80mg/m2，day 1 of every 3 weeks | Drug | Tislelizumab combined with chemotherapy |
Primary outcome
Pathological complete response rate
Time frame: 4 weeks after surgery
Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
2 secondary outcomes
Major pathological response rate
Time frame: 4 weeks after surgery
Objective Response Rate
Time frame: At the end of Cycle 2(each cycle is 28 days)
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 13 Jun 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 Nedaplatin in people with Esophagus Cancer, run by The First Affiliated Hospital of Xiamen University.
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 10 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: opening soon, as of the sponsor's last update on 13 Jun 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 Geng guo jun, Doctor (13365922380 ext. 86, ggj622@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: 4 weeks after surgery). 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 13 Jun 2025.