Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy

Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy - JACCRO CC-07 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010319

Enrollment

Registered

2013-03-26

Start date

2013-03-06

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

Metastatic colorectal cancer

Interventions

TS-1+Irinotecan+Bevacizumab therapy Bevacizumab 7.5mg/m2/tri-weekly Irinotecan 150mg/m2/tri-weekly TS-1 80-120mg/day, for 14 days followed by 1 week rest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)Metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy as first-line (3)Presence of evaluable lesion (4)ECOG Performance Status 0-1 (5)Age equal more 20 years old (6)Life expectancy of more than 3 months (7)Oral food intake possible (8)Patiens have enough organ function for study treatment within 14 days before enrollment WBC>=3,000/mm3, <12,000/mm3 Neu>=1,500/mm3 PLT>=10.0x104/mm3 Hb>=9.0g./dL Total Bilirubin <= 1.5mg/dL AST<=100 IU/L ALT<=100 IU/L Creatinine <=1.2mg/dL Creatinine clearance >=50mL/min Proteinuria<=2+ PT-INR <=1.5 (9)Written informed consent

Exclusion criteria

Exclusion criteria: (1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (2)Symptomatic brain metastases (3)Infectious disease (4)Interstitial lung disease or pulmonary fibrosis (5)Comorbidity or history of heart failure (6)History of thromboembolic events (7)History of hemoptysis (8)Sensory alteration or paresthesia interfering with function (9)Large quantity of pleural, abdominal or cardiac effusion (10)Severe comorbidity (renal failure, liver failure, hypertension, etc) (11)Prior radiotherapy for primary and metastases tumors (12)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breast feeding. Women with a positive pregnancy test (13)History of severe allergy (14)Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 4 weeks (15)Systemic administration of antiplatelet drug or NSAIDs (16)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy (17)Uncontrolled peptic ulcer (18)History of gastrointestinal perforation within 1 year (19)Untreated traumatic bone fracture (20)Require treatment of renal dysfunction (21)Doubting dihydropyrimidine dehydrogenase deficit (22) Uncontrolled diarrhea (23)History of organ recipient (24)Administration of atazanavir sulfate (25Administration of flucytosine (26)Jaundice (27) Ileus or bowel obstruction (28)Any other cases who are regarded as inadequate for study enrollment by investigators

Design outcomes

Primary

Measure	Time frame
6-Month Progression Free Survival Rate	—

Secondary

Measure	Time frame
Overall Survival Progression Free Survival Response Rate Safety	—

Countries

Japan

Contacts

Public ContactMasashi Fujii

Japan Clinical Cancer Research Organization Office

cc07.dc@jaccro.or.jp03-5579-9882

Outcome results

None listed

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