Neo-NTP-CRT for Locally Advanced ESCC

NCT05130684 | Unknown Phase 2

• 1 other identifier: 202005115MIPB
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• change in treatment related death

  no increase of treatment-related death within 30 days after esophagectomy

  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.).

  5 months

Study Arms (1)

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).

Drug: Nivolumab

Interventions

Nivolumab DRUG

adding nivolumab to conventional neoadjuvant CRT

Also known as: paclitaxel, cisplatin, radiation

Neo-CRT

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Nivolumab; Paclitaxel; Cisplatin; Radiation

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Officials

• Chih-Hung Hsu, MD PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ta-Chen Huang, MD

CONTACT

+886223123456; e360215@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 23, 2021
• Study Start: February 22, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)