Phase II study of adjvant Nivolumab monotherapy for esophageal cancer.

JRCT ID: jRCT1031220223

Registered date:25/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 25/07/2022
• Target sample size: 99
• Study type: Interventional

Intervention(s)

Postoperative Nivolumab therapy (52 weeks)
1-16 weeks: 240 mg/body every 2 weeks
17-52 weeks: 480 mg/body every 4 weeks

Outcome(s)

• Primary Outcome: 2-year disease-free survival rate

Secondary Outcome

Disease free survival (DFS)
Disease-free survival rate (1, 5 years)
Overall survival (OS)
Overall survival (1, 2, 5 years)
Distant recurrence-free survival (DMFS)
Frequency of adverse events
Immunological reactivity

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically diagnosed esophageal or esophagogastric junction cancer
2) The patient must have "T3" or "N1 or higher (excluding T4)" (equivalent to Stage II/III excluding T4 in TNM classification) in the 11th edition of theCancer Code of Ethical Treatment of Esophageal Cancer.
3) Age at the time of consent is 18 years or older
4) Performance status (PS) of 0 or 1
5) Radical resection (R0 resection) is obtained after preoperative DCF therapy for esophageal cancer.
6) Surgical pathology has not resulted in pathologic complete response (pCR)
7) No prior administration of immune checkpoint inhibitors, including for other carcinomas
8) Organ function is preserved.
9) Written consent to participate in the study has been obtained from the patient.

Exclude criteria

1) Active overlapping cancers (simultaneous overlapping cancers and iatrogenic overlapping cancers with a disease-free period of 3 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are judged to have been cured by local treatment are not included in active overlapping cancers.
2) Active infection requiring systemic treatment (fever of 38 degree or higher, with imaging or bacteriological evidence of bacterial infection. Local infections that do not affect the general condition are excluded).
3) Confirmed active hepatitis B, hepatitis C or HIV infection.
4) History of interstitial pneumonia, pulmonary fibrosis, radiation pneumonitis or drug-induced pneumonitis, or suspicion of these diseases on imaging
5) Psychosis or psychiatric symptoms that make it difficult to participate in the study.
6) Receiving continuous systemic administration (oral or intravenous) of steroids.
7) Complicated with poorly controlled diabetes mellitus.
8) Complicated unstable angina (angina with on set or worsening attacks within the last 3 weeks) or history of myocardial infarction within 3 months.
9) Comorbid autoimmune disease or a history of chronic or recurrent autoimmune disease
10) History of organ transplant (including hematopoietic stem cell transplant)
11) Tuberculosis infection or history of tuberculosis
12) Pregnant, possibly pregnant, or lactating
13) Other conditions that make participation in this study inappropriate

Related Information

• Primary Sponsor: Yagi Koichi