ESCCPhase 2NICE-ESCCNCT06764355
Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with ESCC and Total Neoadjuvant Treatment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC, Total Neoadjuvant Treatment, Pathological Complete Response
- What is being tested?
- Tislelizumab, Paclitaxel and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jul 2025to Dec 2028
- 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
- Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
- Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by staging procedures (including but not limited to endoscopic ultrasound, computed tomography, bronchoscopy or positron emission tomography):
- cT3/4a, N0, M0;
- cT1-4a, N1-3, M0.
- Tumor length longitudinal ≤ 10cm and radial ≤ 5cm.
- The tumor must not extend more than 2cm into the stomach.
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- No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
- Age ≥ 18 and ≤ 75 years old.
- Performance status ECOG 0~1.
- Adequate bone marrow reserves, defined as:
- white blood cells (WBC) ≥ 3,000/µl or neutrophil count (ANC) ≥ 1,500/µl;
- platelets ≥ 100,000/µl.
- Adequate liver function reserves, defined as:
- hepatic transaminases ≤ 2.5 x upper limit of normal (ULN);
- serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).
- Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation)
- Written informed consent.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be mandatory.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section - Contraception, for the course of the study through 120 days after the last dose of study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Who cannot join
- Adenocarcinoma
- Previous thoracic irradiation
- Previous systemic chemotherapy
- Has received prior therapy with an anti-PD-1 or anti-PD-L1
- Synchronous diagnosis of squamous cell carcinoma in the aerodigestive tract, other than esophageal cancer.
- Prior malignancy, except for the following:
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- adequately treated basal cell or squamous cell skin cancer;
- in-situ cervical cancer;
- a "cured" malignancy more than 5 years prior to enrollment.
- Significant co-morbid disease, which prohibits the conduction of immunochemotherapy, concurrent CRT, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
- Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.
- Pre-existing motor or sensory neurotoxicity greater than grade 1.
- Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.
- Weight loss > 15%.
- Dementia or altered mental status that would prohibit the understanding and completion of informed consent.
- Estimated life expectancy less than 3 months.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis, interstitial lung disease or pulmonary fibrosis.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Patients with untreated chronic HBV or chronic HBV carriers whose HBV DNA is ≥500 IU/mL, or patients with active HCV. Patients who are inactive carriers or with treated and stable hepatitis B (detectable B surface antigen and HBV DNA <500 IU/mL); patients with non-reactive HCV can be enrolled. Patients with chronic HBV infection need to be treated with anti-HBV agents while receiving immunochemotherapy and chemoradiotherapy according to the local and institutional guidelines.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed.
- Has received organ transplantation.
- Has declined esophagectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Chien Huai Chuang, MD, +886911930410, A00723@ntucc.gov.tw
+886911930410, A00723@ntucc.gov.tw
About this study
Official title: Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis.
Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.
- Being tested
- Tislelizumab, Paclitaxel, Cisplatin, Chemoradiotherapy
- Keywords
- ESCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
200 mg, 1h-IVF, Q3W on day 1 for 2 cycles
PaclitaxelDrug
Paclitaxel 175 mg/m2, 3h-IVF, Q3W on day 1 for 2 cycles
CisplatinDrug
Cisplatin 75 mg/m2, 2h-IVF, Q3W on day 1 for 2 cycles
ChemoradiotherapyRadiation
Chemoradiotherapy
- Paclitaxel 50 mg/m2, 1h-IVF, on days 1, 8,15, 22, and 29;
- Cisplatin 30 mg/m2,1h-IVF, on days 1, 8,15, 22, and 29;
- RT: 1.8 Gy/fraction, 5 days a week, for 25 fractions (total dose= 45 Gy).
| Study group | Role | What they receive |
|---|---|---|
| Total Neoadjuvant Therapy | Experimental | "neoadjuvant immunochemotherapy" and "chemoradiotherapy" Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response
To evaluate the pathological complete response (pCR) rate of participants receiving total neoadjuvant therapy with induction immunochemotherapy and chemoradiotherapy (CRT) followed by surgery in operable ESCC.
Measured: through study completion, an average of 6 months
Secondary outcomes (8)
Major pathological response
defined as number of participants with residual tumor cells ≤10% at the time of surgery divided by the number of participants received esophagectomy
Measured: through study completion, an average of 6 months
R0 resection rate
defined as number of participants with no gross residual disease, plus negative section margins (i.e., proximal, distal, and circumferential margins are all > 1 mm) according to pathological examination of esophagectomy specimen.
Measured: through study completion, an average of 6 months
Disease-free survival
defined as the time from esophagectomy until evidence of disease recurrence or death in participants received esophagectomy.
Measured: from esophagectomy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Event-free survival
defined as the time from enrollment to an event which may include radiographic progression, clinical progression, local or distant recurrence, second aerodigestive tract squamous cell carcinoma, and death.
Measured: from enrollment to an event which may include radiographic progression, clinical progression, local or distant recurrence, second aerodigestive tract squamous cell carcinoma, and death from any cause, whichever came first, assessed up to 50 months
Distant metastasis-free survival
defined as the time from esophagectomy until evidence of distant metastasis recurrence or death.
Measured: from esophagectomy until evidence of distant metastasis recurrence or death from any cause, whichever came first, assessed up to 50 months
Overall survival
defined as the time from enrollment to death.
Measured: the time from enrollment to death from any cause, whichever came first, assessed up to 50 months
Loco-regional recurrence rate
defined as number of participants with loco-regional recurrence divided by the number of participants received esophagectomy
Measured: from esophagectomy until evidence of loco-regional metastasis recurrence or death from any cause, whichever came first, assessed up to 50 months
Distant metastasis rate
defined as number of participants with distant recurrence divided by the number of participants received esophagectomy
Measured: from esophagectomy until evidence of distant metastasis or death from any cause, whichever came first, assessed up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start23 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764355
- Sponsor's protocol ID
- 202409007MIPE
- Acronym
- NICE-ESCC
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06764355
- Acronym / sponsor ID
- NICE-ESCC / 202409007MIPE
- Keywords
- ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jan 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.
Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis.
Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Neoadjuvant Therapy | Experimental | Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Radiation: Chemoradiotherapy"neoadjuvant immunochemotherapy" and "chemoradiotherapy" |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
- Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by staging procedures (including but not limited to endoscopic ultrasound, computed tomography, bronchoscopy or positron emission tomography):
- Tumor length longitudinal ≤ 10cm and radial ≤ 5cm.
- The tumor must not extend more than 2cm into the stomach.
- No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
Key exclusion criteria (26 listed)
- Adenocarcinoma
- Previous thoracic irradiation
- Previous systemic chemotherapy
- Has received prior therapy with an anti-PD-1 or anti-PD-L1
- Synchronous diagnosis of squamous cell carcinoma in the aerodigestive tract, other than esophageal cancer.
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 |
|---|---|---|
| Tislelizumab200 mg, 1h-IVF, Q3W on day 1 for 2 cycles | Drug | Total Neoadjuvant Therapy |
| PaclitaxelPaclitaxel 175 mg/m2, 3h-IVF, Q3W on day 1 for 2 cycles | Drug | Total Neoadjuvant Therapy |
| CisplatinCisplatin 75 mg/m2, 2h-IVF, Q3W on day 1 for 2 cycles | Drug | Total Neoadjuvant Therapy |
| ChemoradiotherapyChemoradiotherapy * Paclitaxel 50 mg/m2, 1h-IVF, on days 1, 8,15, 22, and 29; * Cisplatin 30 mg/m2,1h-IVF, on days 1, 8,15, 22, and 29; * RT: 1.8 Gy/fraction, 5 days a week, for 25 fractions (total dose= 45 Gy). | Radiation | Total Neoadjuvant Therapy |
Primary outcome
pathological complete response
Time frame: through study completion, an average of 6 months
To evaluate the pathological complete response (pCR) rate of participants receiving total neoadjuvant therapy with induction immunochemotherapy and chemoradiotherapy (CRT) followed by surgery in operable ESCC.
8 secondary outcomes
Major pathological response
Time frame: through study completion, an average of 6 months
R0 resection rate
Time frame: through study completion, an average of 6 months
Disease-free survival
Time frame: from esophagectomy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Event-free survival
Time frame: from enrollment to an event which may include radiographic progression, clinical progression, local or distant recurrence, second aerodigestive tract squamous cell carcinoma, and death from any cause, whichever came first, assessed up to 50 months
Distant metastasis-free survival
Time frame: from esophagectomy until evidence of distant metastasis recurrence or death from any cause, whichever came first, assessed up to 50 months
Overall survival
Time frame: the time from enrollment to death from any cause, whichever came first, assessed up to 50 months
Loco-regional recurrence rate
Time frame: from esophagectomy until evidence of loco-regional metastasis recurrence or death from any cause, whichever came first, assessed up to 50 months
Distant metastasis rate
Time frame: from esophagectomy until evidence of distant metastasis or death from any cause, whichever came first, assessed up to 50 months
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 27 Jan 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?
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with ESCC and Total Neoadjuvant Treatment, run by National Taiwan University Hospital at 1 site in Taiwan.
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 22 inclusion and 26 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 27 Jan 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 Taiwan. 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?
Contact Chih-Hung Hsu, M.D., PhD (+886-2-23123456 ext. 67680, chihhunghsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (time frame: through study completion, an average of 6 months). 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 27 Jan 2026.