Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies

Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies - Phase II study of S-1 plus bevacizumab as the third-line therapy in advanced colorectal cancer (CCOG-1105; C3-03 study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006476

Enrollment

Registered

2011-10-06

Start date

2011-10-01

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

S-1 plus bevacizumab therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histopathologically confirmed colorectal cancer. (2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin- and irinotecan-based therapies with bevacizumab. (3) Measurable or evaluable disease (RECIST ver.1.1.). (4) Colorectal cancer with Kras mutant type gene. (5) Age of 20 years or older. (6) ECOG performance status 0-1. (7) Life expectancy greater than 3 months. (8) Written informed concent. (9) Adequate organ function.

Exclusion criteria

Exclusion criteria: (1) Uncontrolled infection. (2) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (3) Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. (4) Severe lung disease. (5) Interstitial lung disease or pulmonary fibrosis. (6) Severe liver disease. (7) Severe renal failure, or urinary protein (more than 2+). (8) Previous history of severe drug-induced allergy (9) Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. (10) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). (11) History of active double cancer. (12) Massive pleural effusion or ascites that required drainage. (13) Brain metastasis (14) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. (15) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (16) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (17) Not appropriate for the s

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity	—

Countries

Japan

Contacts

Public ContactTakahiro Asada, Koji Torii

Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery

goro@med.nagoya-u.ac.jp(81)52-744-2250

Outcome results

None listed

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