Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Overview
- Phase
- Phase 2
- Intervention
- Nivolumab
- Conditions
- Locally Advanced Esophageal Squamous Cell Carcinoma
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- change in treatment related death
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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, M
- •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\~
- •Adequate bone marrow reserves, defined as:
Exclusion Criteria
- •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.
Arms & Interventions
Neo-CRT
* 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).
Intervention: Nivolumab
Outcomes
Primary Outcomes
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.).