A phase I study of alternate-day administration of S-1 plus leucovorin with bevacizumab in patients with refractory metastatic colorectal cancer.

A phase I study of alternate-day administration of S-1 plus leucovorin with bevacizumab in patients with refractory metastatic colorectal cancer. - A phase I study of alternate-day administration of S-1 plus leucovorin with bevacizumab in patients with refractory metastatic colorectal cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016094

Enrollment

Registered

2014-12-31

Start date

2015-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

alternate-day administration of S-1 plus leucovorin with bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically proven adenocarcinoma of colorectal cancer (2) With evaluable disease according to RECIST version1.1 (3) Resistant or intolerable to fluoropyrimydine, oxaliplatin, irinotecan, bevacizumab and anti-EGFR antibody (4) ECOG Performance Status of 0 or 1 (5) >=20 years old (6) Life expectancy of more than 3 months. (7) Adequate oral intake (8) Adequate organ function (9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Active multiple malignancy (2) History of severe drug-induced hypersensitivity (3) Symptomatic brain metastasis (4) Active infection (5) Interstitial pneumonia or pulmonary fibrosis (6) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus). (7) massive pleural or abdominal effusion (8) Diarrhea (9) Administration of phenytoin or flucytosine (10) Systemic administration of steroid (11) Thromboembolism (grade 3 or higher), myocardial infarction, brain infarction, or pulmonary embolism within 6 months before enrollment (12) Any major surgery or open biopsy within 4 weeks before enrollment (13) Systemaic administration of antiplatelet drugs or NSAIDs (14) Bleeding diathesis, coagulopathy or administration of anticoagulation (15) Active peptic ulcer (16) History of gastrointestinal perforation within 1 year before enrollment (17) Clinically significant mental disorder (18) Positive for HBs antigen (19) Women who are pregnant or patients who are unwilling to avoid pregnancy (20) Patients who are inappropriate for the study in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
recommended dose	—

Secondary

Measure	Time frame
safety relative dose intensity response rate disease control rate progression free survival time to treatment failure overall survival QOL	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Aichi Cancer Center Hospital Department of Clinical Oncology

tmasuishi@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026