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Esophagus CancerPhase 2NCT06692270

Tislelizumab as Single-Agent Neoadjuvant Immunotherapy in Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Tislelizumab in people with Esophagus Cancer, run by Fujian Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Tislelizumab in resectable esophageal squamous cell carcinoma 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 May 2025to 10 Jan 2027
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

  • 18 years old ≤75 years old, male or female;
  • T2-3N0-+M0 or T1bN+M0 thoracic esophageal squamous cell carcinoma (as defined in AJCC 8th Edition) with a definite gastroscopic biopsy.
  • There is at least one measurable lesion (RECIST1.1 standard);
  • ECOG PS 0~1;
  • Expected survival ≥ 12 months;
  • Newly diagnosed patients who have not received surgery, chemoradiotherapy, targeted therapy, immunotherapy and other treatments before;
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  • Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment. Male subjects and women of reproductive age must be on contraception within 24 weeks of starting the first study drug and the last study drug.
  • The laboratory test value of the patient before medication shall meet the following criteria:
  • Blood routine: WBC≥3.0 × 109/L; ANC≥1.5 × 109/L; PLT≥100 × 109/L; HGB≥ 9.0g /dL
  • Liver function: AST≤2.5 × ULN, ALT≤2.5 × ULN, TBIL≤1.5 × ULN
  • Renal function: Cr≤1.5 × ULN or CrCl ≥50 mL/min
  • Coagulation function: INR≤1.5, APTT≤1.5 ×ULN;
  • Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

  • Esophageal adenocarcinoma was confirmed by histological or cytological pathology;
  • Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T cell-targeting drugs;
  • A previous or current history of cancer other than esophageal cancer, other than non-melanoma skin cancer that has been treated therapeutically, cervical cancer in situ, or other cancer that has been treated therapeutically and has not shown signs of recurrence for at least 5 years;
  • Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms or severe lung dysfunction;
  • Uncontrolled hypertension with standard treatment (blood pressure not stabilized below < 150/90 mmHg);
  • Hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline;
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  • Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 24 weeks, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
  • Severe infections (CTCAE > Class 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred within 4 weeks prior to the first use of the study drug;
  • Patients with clinically uncontrollable third space effusion (such as pleural effusion/pericardial effusion, who do not need to drain the effusion or have no significant increase in effusion after 3 days of stopping drainage can be included in the group);
  • Imaging (CT or MRI) shows that the tumor has invaded the major blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
  • A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Patients with active hepatitis B (defined as positive HBV surface antigen [HBsAg] test result during screening and HBV-DNA test value higher than the upper limit of normal value in the laboratory of the research center) or hepatitis C (defined as positive HCV surface antibody [HCsAb] test result during screening and HCV-RNA positive);
  • Those who have allergic reaction to the experimental drug used in this application;
  • According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study.

About this study

Official title: Tislelizumab as Single-Agent Neoadjuvant Immunotherapy in Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm, Phase II Clinical Study（TISNEOS）

Tislelizumab in resectable esophageal squamous cell carcinoma

Being tested
Tislelizumab
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06692270
Study groupRoleWhat they receive
TislelizumabExperimentalNot described
Receives: Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response

    Total 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)

  1. Major pathological response

    Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

    Measured: 4 weeks after surgery

  2. 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 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start15 May 2025 (estimated)
  3. Primary completion10 Jan 2026 (estimated)
  4. Study completion10 Jan 2027 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692270
Sponsor's protocol ID
TISNEOS
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
28 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab 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 13 inclusion and 14 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 28 Feb 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?

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 (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?

On the ClinicalTrials.gov record for NCT06692270.

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 28 Feb 2025.

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