Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2Neo-NTP-CRTNCT05130684
Neo-NTP-CRT for Locally Advanced ESCC
A Phase 2 study testing Nivolumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesize that nivolumab combined with neoadjuvant chemoradiotherapy (CRT) is safe and effective in patients with locally advanced esophageal squamous cell carcinoma (LAESCC). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2021to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 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 endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
- cT3/4a, N0, M0;
- cT1-3, N1-3, M0.
- Tumor length longitudinal ≤ 8cm 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 ≥ 20 and ≤ 75 years old.
- Performance status ECOG 0~1.
- Adequate bone marrow reserves, defined as:
- white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/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 required.
- 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, anti-PD-L1, or anti-PD-L2 agent.
- Synchronously diagnosed squamous cell carcinoma of aerodigestive way, 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 chemotherapy, concurrent chemo- radiotherapy, 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.
- Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease.
- 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).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., anti-HCV reactive and HCV RNA [qualitative] are detected).
- Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA.
- 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 (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has received organ transplantation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ta-Chen Huang, MD, +886223123456 ext. 71669, e360215@gmail.com
About this study
Official title: Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
The investigators hypothesize that nivolumab combined with neoadjuvant chemoradiotherapy (CRT) is safe and effective in patients with locally advanced esophageal squamous cell carcinoma (LAESCC).
- Being tested
- Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called paclitaxel, cisplatin, radiation
adding nivolumab to conventional neoadjuvant CRT
| Study group | Role | What they receive |
|---|---|---|
| Neo-CRT | Experimental | * Nivolumab 240 mg, 30-min IVF, Q2W on days -14, 1, 15, and 29;
* 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). Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in treatment related death
no increase of treatment-related death within 30 days after esophagectomy
Measured: 30 days
rate of completion of protocol treatment
successful completion of preoperative therapy and processing to surgery without any extended treatment-related delay, which is defined as > 19 weeks after the first dose of nivolumab (d-14) in neo-NTP-CRT (19 weeks include 15 weeks of protocol treatment plus 4 weeks of flexibility.).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start22 Feb 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Hung Hsu, MD PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130684
- Sponsor's protocol ID
- 202005115MIPB
- Acronym
- Neo-NTP-CRT
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang TC, Guo JC, Lin CC, Kuo HY, Chuang CH, Cheng JC, Hsu FM, Lee JM, Huang PM, Liang CW, Li YI, Hsu CH. Neoadjuvant immunochemoradiotherapy with nivolumab, paclitaxel, and cisplatin followed by esophagectomy for locally advanced esophageal squamous cell carcinoma. Br J Cancer. 2026 May;134(10):1403-1412. doi: 10.1038/s41416-026-03349-6. Epub 2026 Mar 20.
PubMed 41862680
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
- ClinicalTrials.gov ID
- NCT05130684
- Acronym / sponsor ID
- Neo-NTP-CRT / 202005115MIPB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 23 Nov 2021 (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.
The investigators hypothesize that nivolumab combined with neoadjuvant chemoradiotherapy (CRT) is safe and effective in patients with locally advanced esophageal squamous cell carcinoma (LAESCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neo-CRT | Experimental | Drug: Nivolumab* Nivolumab 240 mg, 30-min IVF, Q2W on days -14, 1, 15, and 29; * 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). |
Who may qualify
- Ages
- 20 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 endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
- Tumor length longitudinal ≤ 8cm 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 (27 listed)
- Adenocarcinoma.
- Previous thoracic irradiation.
- Previous systemic chemotherapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Synchronously diagnosed squamous cell carcinoma of aerodigestive way, 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 |
|---|---|---|
| NivolumabAlso: paclitaxel, cisplatin, radiationadding nivolumab to conventional neoadjuvant CRT | Drug | Neo-CRT |
Primary outcome
change in treatment related death
Time frame: 30 days
no increase of treatment-related death within 30 days after esophagectomy
rate of completion of protocol treatment
Time frame: 5 months
successful completion of preoperative therapy and processing to surgery without any extended treatment-related delay, which is defined as > 19 weeks after the first dose of nivolumab (d-14) in neo-NTP-CRT (19 weeks include 15 weeks of protocol treatment plus 4 weeks of flexibility.).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 41862680Huang TC, Guo JC, Lin CC, Kuo HY, Chuang CH, Cheng JC, Hsu FM, Lee JM, Huang PM, Liang CW, Li YI, Hsu CH. Neoadjuvant immunochemoradiotherapy with nivolumab, paclitaxel, and cisplatin followed by esophagectomy for locally advanced esophageal squamous cell carcinoma. Br J Cancer. 2026 May;134(10):1403-1412. doi: 10.1038/s41416-026-03349-6. Epub 2026 Mar 20.
- 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. This study is not recruiting at the moment.
Chih-Hung Hsu, MD PhD principal investigator
National Taiwan University Hospital
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 Nivolumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma, 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 27 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ta-Chen Huang, MD (+886223123456 ext. 71669, e360215@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in treatment related death (time frame: 30 days). 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 NCT05130684, 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 23 Nov 2021.