AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2ETNTNCT05189730

Selected Chemotherapy Combined Immunotherapy Treated High Risk Patient After NCRT in Resected Locally Advanced ESCC

A Phase 2 study testing Tirelizumab, Paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC. And then the patients would receive surgery and adjuvant therapy according to the postoperative pathological results. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Tirelizumab, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Jul 2021to 31 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

  • 1.Histologically confirmed ESCC；
  • 2.Clinical stage T2N0-1M0, T3N0M0, T3N1M0, T1-3N2M0（II-III) (AJCC 8 TNM classif tion);
  • 3.Locally advanced ESCC that can be treated surgically evaluated before treatment;
  • 4.At least one measurable lesion in accordance with RECIST 1.1;
  • 5.Have a performance status of 0 or 1 on the ECOG Performance Scale;
  • 6.Expected survival time is greater than 6 months;
Show all 9Show fewer
  • 7.The important organs functions meet the following requirements:the absolute neutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L; bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5 times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
  • 8.Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
  • 9.Be willing and able to provide written informed consent/assent for the trial.

Who cannot join

  • 1.The patient have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy;
  • 2.Confirmed patients with distant metastasis by CT imaging;
  • 3.The subject has previous or co-existing other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • 4.The subject had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1;
  • 5.Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;
  • 6.Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone > 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study;
Show all 20Show fewer
  • 7.Clinical ascites or pleural effusion requiring therapeutic puncture or drainage;
  • 8.The subject with uncontrol cardiac clinical symptoms or diseases, such as :(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention;
  • 9.Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg> 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment;
  • 10.The subject is present (within 3 months) with esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or with active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
  • 11.Past or present severe bleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4 weeks) or thromboembolism events (including stroke events and/or TRANSIENT ischemic attack) within 12 months;
  • 12.Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study;
  • 13.Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc;
  • 14.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
  • 15.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
  • 16.Patients who had participated in clinical trials of other drugs within 4 weeks;
  • 17.The live vaccine was administered less than 4 weeks prior to study administration or possibly during the study period;
  • 18.Have a history of mental illness or psychiatric substance abuse;
  • 19.The subject cannot or does not agree to bear the cost of the self-paid portion of the examination and treatment, except for the clinical study drug, combined chemoradiotherapy, and SAE associated with the clinical study drug;
  • 20.Other patients whom the medical practitioner considers inappropriate for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Selected Chemotherapy Combined Immunotherapy Treated High Risk Patient After Neoadjuvant Chemoradiotherapy in Resected Locally Advanced Esophageal Squamous Cell Carcinoma: an Exploratory Study

Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC. And then the patients would receive surgery and adjuvant therapy according to the postoperative pathological results. It is expected that through this study, some high-risk patients could obtain better efficacy and prolong patient survival. At same time, low risk patients could avoid increasing perioperative complications and surgical risks, so that more patients could benefit from neoadjuvant treatment. The investigators aimed to explore a more accurate comprehensive treatment mode for patients with esophageal squamous cell carcinoma, and provide a certain scientific basis for the formulation of esophageal cancer diagnosis and treatment norms in China.

Being tested
Tirelizumab, Paclitaxel, Carboplatin, Neoadiuvant radiotherapy
Keywords
neoadjuvant treatment, immunotherapy, chemoradiotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • TirelizumabDrug

    Two cycles of Tirelizumab (200mg administered as an intravenous infusion over 30 minutes per 3 weeks), D1.

  • PaclitaxelDrug

    Two cycles of paclitaxel (135mg/m2 administered as an intravenous infusion per 3 weeks), D1.

  • CarboplatinDrug

    Two cycles of carboplatin(AUC=5 administered as an intravenous infusion per 3 weeks) D1.

  • Neoadiuvant radiotherapyRadiation

    Simultaneous radiotherapy would be consecutively performed for 4 weeks with the total dose of 40Gy (40Gy/ 4W /20F), D1.

Study groups in NCT05189730
Study groupRoleWhat they receive
Total neoadjuvant therapyExperimentalThe patients would receive neoadjuvant chemoradiotherapy treatment firstly. And then evaluated efficacy according to RECIST 1.1. If patients with cCR would receive surgery treatment after 4-6 weeks. After surgery, patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy alone treatment. If patients evaluated as PD, they would receive new treatment regimen after MDT discussed. Other patients with PR and SD would receive 2 cycles of neoadjuvant immunochemotherapy. And then, Efficacy of immunochemotherapy would be evaluated according to RECIST 1.1. For patients suitable for surgery, surgery should be performed after 4-6 weeks of immunotherapy. After surgery, the patients with R0 resection would divided into two groups, if patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy treatment. Other patients without R0 resection would receive new treatment regimen after MDT discussed.
Receives: Drug: Tirelizumab; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Neoadiuvant radiotherapy

What is being measured

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

  1. Complete pathologic response rate

    Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"

    Measured: 3 months

  2. Incidence of adverse events

    Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0

    Measured: 6 months

Secondary outcomes (6)

  1. Clinical Complete Remission

    The clinical complete remission rate (cCR) was defined as the proportion of patients with clinically confirmed cT0 or cN0(AJCC Cancer Staging Manual,8th ed. 2017 edition ).

    Measured: 3 months

  2. Major Pathological Remission rate

    The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline。

    Measured: 3 months

  3. Objective Remission Rate

    Objective response rate as assessed by RECISIST1.1 criteria, the percentage of subjects with CR or PR in the total number of subjects in the analysis data set during the period from the beginning of the treatment regimen to the disease progression date.

    Measured: 3 months

  4. Rate of R0 resection

    Measure the rate of R0 resection with all margins microscopically clear.

    Measured: 3 months

  5. Events Free Survival

    Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol.

    Measured: Through study completion, an average of 1 year.

  6. Overall Survival

    Overall survival was the duration from the start of study treatment to death

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Timeline

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

  1. First posted12 Jan 2022
  2. Study start1 Jul 2021
  3. Primary completion31 Jan 2025
  4. Study completion31 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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05189730
Sponsor's protocol ID
SCCH-TS2107
Acronym
ETNT
Status last verified
Nov 2025
First submitted
26 Nov 2021
Last updated
20 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • He W, Wang C, Wu L, Wan G, Li B, Han Y, Li H, Leng X, Du K, Chen H, Wang Q, Peng L. Tislelizumab Plus Chemotherapy Sequential Neoadjuvant Therapy for Non-cCR Patients After Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ETNT): An Exploratory Study. Front Immunol. 2022 Jun 2;13:853922. doi: 10.3389/fimmu.2022.853922. eCollection 2022.

    PubMed 35720312

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirelizumab, Paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research 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 9 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. 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?

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?

Complete pathologic response rate (time frame: 3 months). 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 NCT05189730, 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 20 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in