Phase II study of Nivolumab under high fiber intake in immunotherapy-resistant solid tumors

JRCT ID: jRCTs031230606

Registered date:30/01/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Non-small cell lung cancer
Esophageal cancer
Gastric cancer

• Date of first enrollment: 30/01/2024
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Nivolumab was administered in 28-day cycles until unmanageable toxic effects or clinical disease progression occurred. Take 6 grams of dietary fiber from beans three times a day.

Outcome(s)

• Primary Outcome: Rate of progression-free survival at 6 months

Secondary Outcome

Rate of objective response
Progression-free survival
Overall survival
Adverse events

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically confirmed non-small cell lung cancer (Cohort 1), esophageal cancer (Cohort 2), or gastric cancer (Cohort 3)
2) Patients with acquired resistance to cancer immunotherapy
3) Patients with evaluable disease according to RECIST ver1.1
4) No symptomatic brain metastases
5) Patients with a performance status (ECOG criteria) of 0-1
6) Patients must be at least 18 years of age at the time of consent.
7) The specified period of time since prior treatment or completion of the procedure has elapsed.
8) Patients with no severe disease in major organs (bone marrow, lung, liver, kidney, etc.)
9) Patients who are expected to survive at least 3 months
10) Written informed consent has been obtained from the patient.

Exclude criteria

1) Patients with active overlapping cancers
2) Patients with local or systemic active infections requiring drainage or other surgical procedures.
3) Patients with active hepatitis B or active hepatitis C (HBs antigen positive patients are eligible if their viral load is less than sensitive and they do not have active hepatitis).
4) Patients with interstitial lung disease evident on chest radiographs.
5) Patients with pericardial, pleural or ascites effusions requiring drainage.
6) Patients with serious immune-related adverse events (irAEs) during previous cancer immunotherapy.
7) Patients with concomitant autoimmune disease or a history of autoimmune disease requiring steroid therapy.
8) Patients with non-autoimmune diseases requiring continuous systemic oral or intravenous administration of steroids at doses higher than 10 mg/day of prednisolone equivalent, and patients on immunosuppressive drugs.
9) Patients with a history of hypersensitivity to any component or additive of nivolumab.
10) Pregnant women, lactating women, women who may be currently pregnant, or patients who are unwilling to use contraception.
11) Patients with clinically problematic psychiatric disorders that would preclude enrollment in this study.
12) Other patients deemed inappropriate by the investigators.

Related Information

• Primary Sponsor: Horiike Atsushi
• Secondary Sponsor: Tsunoda Takuya
• Source(s) of Monetary Support: Taiyo Kagaku Corporation