A phase II clinical trial exploring toxicity and efficacy of irinotecan combined S1 as first-line therapy for advanced gastric cancer according to the UGT1A1 genotype

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OCH-12002472

Enrollment

Unknown

Registered

2012-08-28

Start date

2012-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Advanced gastric cancer

Interventions

wild type:genetic test

homozygous mutation:genetic test

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histology or cytology diagnose for advanced gastric cancer; 2. At least, there is a measurable tumor objective lesions, spiral CT examination or PET - CT, the largest diameter shall be >=1cm, common CT or MRI, the largest diameter shall be >=2cm; 3. Aged >=18 years old, physical condition ECOG score 0-2, expected surial period >=3 months; 4. Already stop chemotherapy or radiation therapy 3 weeks before evolved in this group,and already recover from toxic reaction of previous treatment. Delayed toxic reaction drugs (such as mitomycin or nitroso urea) treatment should be stopped for 6 weeks; 5. Granulocyte count >=1.5*10^9/L, platelet count >80*10^9/L; 6. Serum bilirubin must <=1.5 times upper limit of normal (ULN). AST, ALT<=2.5 times upper limit of normal (ULN)(if liver metastasis, <=5 times upper limit of normal); 7. Serum creatinine <=1.5 times upper limit of normal (ULN); 8. Can comply with research and follow-up program; 9. For all possible pregnant women, a pregnancy test must be done 72 hours before treatment and results should be negative.

Exclusion criteria

Exclusion criteria: 1. any unstable systemic disease (including the digestive tract ulcer, active infection, level 4 high blood pressure, unstable angina pectoris, congestive heart failure, liver, kidney, metabolic disease or fracture, wound has healed); 2. central nervous system (CNS) transfer than can't control; 3. any other other malignant tumor (completely cure cervical carcinoma in situ or basal cell or squamous cell cancer except) within 5 years; 4. serious ascites and pleural effusion and pericardial effusion, can't treat or control through the drainage or symptomatic; 5. patients with systemic infection, infective wound deferment; 6. pregnancy or lactation women; 7. Known allergy to irinotecan and S1 drugs.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose;Dose limit toxicity;	—

Secondary

Measure	Time frame
objectiv remission rate;Disease progress time;	—

Countries

China

Contacts

Public ContactLi Qiu

qiuli108@yahoo.com.cn+86 18980601131

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026