Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer - Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005199

Enrollment

Registered

2011-03-05

Start date

2011-03-01

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

Metastatic colorectal cancer

Interventions

Bevacizumab with SOX (S-1 plus L-OHP) repeat every 21 days until discontinuance criteria.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) Metastatic colorectal cancer (3) Patients with comfirmed target lesion (4) Patients with metastatic colorectal cancer who had previously received first-line therapy with an irinotecan-based regimen. (5) Life expectancy of more than 3 months (6) Age over 20 (7) ECOG Performance Status 0-1 (8) Patients have enough organ function for study treatment. (9) Enable to internal use (10) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of severe allergy (2) Active double cancer (3) Severe infectious disease (4) Peripheral neuropathy (5) Uncontrolled hypertention (6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc) (7) Massive pleural or abdominal effusion (8) Patient with the diarrhea (9) Symptomatic brain metastases (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (11) Severe mental disorder (12) Systemic administration of corticosteroids (13) Uric protein 2+ (14) Prior radiotherapy for primary and metastases tumors (15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months (16) Patients who underwent surgery within 4 weeks (17) Systemic administration of antiplatelet drug (18) Patients with known bleeding disorders or clotting disorder (19) Previous history of adjuvant chemotherapy with L-OHP (20)Any other cases who are regarded as inadequate for study enrollmet by investigators

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression Free Survival(PFS) Overall Survival(OS) Safety	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Tsuchiura kyodo general hospital Department of Gastroenterology

Outcome results

None listed

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