Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.

Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy. - Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.(KSCC1102)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006307

Enrollment

Registered

2011-09-08

Start date

2011-08-04

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

CPT-11 150mg/m2 i.v. (day1) Bev 7.5mg/kg i.v. (day1) S-1 80mg/m2 p.o. (day1-14) to be repeated every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Appropriate for the study at the physician's assessment 3) Histopathology confirmed colorectal cancer. 4) Previously received oxaliplatin-based chemotherapy as 1st-line chemotherapy. 5) No prior radio-therapy for target lesion. 6) Aged 20<= years 7) ECOG performance status of 0-1. 8) At least one measurable lesion based on the RECIST criterion. (within 28 days before registration). 9) Be able to take oral drugs 10) Required baseline laboratory parameters (within 14 days before registration): WBC: >= 3000 ,<=12000/mm3 Neu: >= 1,500/ mm3 Plt: >= 100,000/ mm3 Hb: >= 9.0g/dL T-Bil: <= 2.0mg/dL AST,ALT: <= 100IU/L (<= 200IU/L if with Liver metastasis) Cre: <1.5mg/dL Ccr: >= 50mL/min Urinary protein: <= grade1 (+1 or 0.15-1.0g/24h) UGT1A1 genotype: wild type and *6,*28 heterozygote 11) Life expectancy at least 3 months.

Exclusion criteria

Exclusion criteria: 1) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension) 2) Symptomatic or asymptomatic but treated heart disease 3) Active infection.. 4) Pleural effusion, peritoneal fluid 5) History of serious drug hypersensitivity or a history of drug allergy 6) Active other malignancies. 7) History of mental disturbances or cerebrovascular attack, central nervous system disorder 8) Brain metastasis 9) Peptic ulcer, bleeding, intestinal obstruction, intestinal paralysis , gastrointestinal perforation 10) History of gastrointestinal perforation 11) Watery stools or grade 2 or more diarrhea 12) History of thromboembolism, cerebral infarction 13) Hemorrhagic diathesis, coagulation disorder 14) Requiring anti-thrombogenic therapy to prevent thrombosis 15) Requiring steroid drug 16) Receiving flucytosine, atazanavir sulfate 17) Pregnant or lactating woman 18) No birth-control 19) Treatment history of irinotecan 20) History of hemoptysis 21) Contraindication to S-1, CPT-11, bevacizumab 22) High-grade stricture 23) Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Response rate Overall Survival Time to Treatment Failure Safety Investigation of Nausea and vomiting Quality of life	—

Countries

Japan

Contacts

Public ContactKSCC

Clinical Research Support Center Kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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