NeoNivo study

JRCT ID: jRCTs031230018

Registered date:11/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: MSI-H/dMMR locally advanced colorectal cancer
• Date of first enrollment: 17/04/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): neoadjuvant treatment of Nivolumab

Outcome(s)

• Primary Outcome: overall response rate

Secondary Outcome

Pathological complete response (pCR) rate
Clinical complete response (cCR) rate
Clinical response (cCR and nCR) rate
Radical resection rate
Protocol treatment completion rate
Distant free survival (DMFS)
Overall survival (OS)
Quality of life assessment (EORCQ-30 and short form 36 health survey questionnaire)
Incidence of postoperative adverse events determined by Clavien-Dindo classification v2.0
Incidence of preoperative treatment-related adverse events determined by CTCAE ver5.0

Key inclusion & exclusion criteria

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

Include criteria

1.The content of this study was fully explained, and written informed consent was obtained from the subject.
2.Histologically confirmed colorectal adenocarcinoma.
3.Radical resection is clinically possible without any distant metastases in imaging.
4.Patients with MSI-H or dMMR.
5.At least 18 years of age on the date of consent.
6.ECOG Performance Status is 0-1
7.No prior treatment for the tumor.
8.Cases with cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition
9.Patients whose functions of the main organs are adequately maintained.

Exclude criteria

1.Extensive surgery (excluding colostomy and central venous porting) within 4 weeks before starting protocol therapy.
2.Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
3.Colonic stent.
4.Contraindications for magnetic resonance imaging (MRI), such as cardiac pacemakers.
5.Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).
6.Active multiple cancers (simultaneous or metachronous multiple cancers with a disease-free interval 5 years or over). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can be cured by local treatment, are not considered active multiple cancers.
7.Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.
8.Hepatitis B (HB) antigen positive or Hepatitis C virus (HCV) antibody positive. However, HCV-RNA-negative can be registered.
9.Positive for human immunodeficiency virus (HIV) infection.
10.Received live vaccine within 30 days prior to the start of study drug administration.
11.With complicated autoimmune disease or a history of chronic or recurrent autoimmune disease.
12.With administration of systemic corticosteroids (except for prophylactic administration for examination or allergic reactions or temporary use to reduce edema associated with radiation therapy) or immunosuppressive agents, or has received such treatment within 14 days prior to enrollment in this study.
13.With unhealed wounds, ulcers, or fractures.
14.Unwillingness or inability to comply with the clinical trial protocol.
15.Other patients that the principal investigator or co-investigator deems ineligible for this study.

Related Information

• Primary Sponsor: Watanabe Jun