PhaseII study of initial 480 mg administration of postoperative adjuvant nivolumab in patients with esophageal cancer

JRCT ID: jRCT1051220172

Registered date:22/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 12/04/2022
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: Nivolumab-related adverse event (irAE) Grade 3 or higher incidence (CTCAE Ver.5.0)
• Secondary Outcome: 1-year treatment completion rate, disease-free survival, overall survival, overall survival, nutritional indicators (body weight, albumin, lymphocyte count)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old

Include criteria

1. Histologically diagnosed squamous cell carcinoma or adenocarcinoma by endoscopic biopsy of primary esophageal tumor
2. Clinical stage cStage II/III/IV (positive supraclavicular lymph node metastasis, including cT4 cases) in diagnostic imaging before preoperative treatment (UICC-TNM 8th)
3. Patients who received preoperative chemotherapy or preoperative radiotherapy (regardless of the number of courses or the dose of anticancer drugs/irradiation dose)
4. R0 resection of esophageal cancer has been performed
5. Positive lymph node metastasis on histopathological examination of resected specimen.
6. Treatment can be started within 16 weeks after radical resection of esophageal cancer
7. Age at the time of registration is 20 years old or older and 85 years old or younger
8. Performance status (PS) is 0 or 1 according to ECOG criteria
9. Patients with maintained organ function who can be treated with nivolumab as neoadjuvant therapy

Exclude criteria

1 Pathological complete response to preoperative chemotherapy or preoperative radiochemotherapy
2 Cases other than subtotal esophagectomy lower esophagectomy, cervical esophagectomy, total pharyngolaryngoesophagectomy, etc
3 Patients with distant metastases other than supraclavicular lymph nodes
4 History or suspected interstitial lung disease
5 Cases requiring systemic treatment for active autoimmune disease with steroid therapy or other immunosuppressive drugs
6 History of immunotherapy including other cancer types
7 Active multiple cancers
8 Difficulty in nivolumab treatment due to major organ abnormalities
9 Patients with a history of severe drug hypersensitivity
10 Pregnant women, breastfeeding women, and women who may or intend to become pregnant
11 Cases deemed inappropriate by the investigator

Related Information

• Primary Sponsor: Miyata Takahito Hiroshi