Postoperative adjuvant therapy with nivolumab in patients with esophageal cancer

JRCT ID: jRCT1051220153

Registered date:22/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Thoracic esophageal cancer
• Date of first enrollment: 09/02/2023
• Target sample size: 130
• Study type: Interventional
• Intervention(s): For the administration of immune checkpoint inhibitors to postoperative patients with esophageal cancer, nivolumab is administered at a dose of 480 mg intravenously every 4 weeks. Duration of treatment should be up to 12 months.

Outcome(s)

• Primary Outcome: disease free survival
• Secondary Outcome: overall survival, distant metastases free survival, percentage of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible
1.Primary tumor is located in the thoracic esophagus and is histologically diagnosed as squamous cell carcinoma by endoscopic biopsy.
2.Patient underwent radical resection after preoperative DCF therapy without pathologic complete response.
3.Patients must be at least 18 years of age on the date of enrollment.
4.Gender is irrelevant.
5.PS is 0 or 1 by ECOG criteria.
6.Patients can be enrolled between 4-16 weeks (28-112 days postoperatively) after complete resection.
7.Patients must be confirmed disease-free by thoracoabdominal CT within 4 weeks prior to enrollment.
8.The latest laboratory values within 14 days prior to enrollment (the same day of the week 2 weeks prior to enrollment is acceptable) meet all of the following
9.The patient has given his/her free and voluntary written consent to participate in this clinical research.

Exclude criteria

Patients with any one of the following will be excluded
1) Have an active systemic infection.
2) Have an active autoimmune disease.
3) Requires treatment with systemic corticosteroids (prednisone equivalent >10 mg/day; inhaled and topical steroids and hormone replacement therapy are acceptable) or other immunosuppressive agents (use for adverse events is acceptable).
4) Currently or previously receiving treatment with immune checkpoint inhibitors.
5) History of interstitial lung disease or extensive findings of these on CT.
6) Other patients deemed inappropriate by the investigators of this clinical study.
7) Unwilling contraceptive patients and pregnant and lactating women.

Related Information

• Primary Sponsor: Goto Hironobu