Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-RCH-11001176

Enrollment

Unknown

Registered

2011-01-22

Start date

2011-02-01

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

colorectal cancer

Interventions

Total:FOLFIRI based chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal cancer; 2. Age >=18 years old; 3. Measurable disease foci, defined as to RECIST criteria; 4. Unresectable metastatic disease OR first recurrence/metastasis after adjuvant therapy and not suitable for operation; 5. FOLFIRI±cetuximab/bevacizumab as the first-line therapy; 6. Without expected course of radiotherapy during the first-line chemotherapy; 7. No previous CPT-11 chemotherapy; 8. KPS>=60% for ECOG performance status (PS) 0-2; 9. Not pregnant or nursing and Negative pregnancy test; 10. Voluntarily sign the informed consent; 11. Total bilirubin <=1.5 times upper limit of normal (ULN); 12. AST and ALT <=2.5 times ULN (<= 5 times ULN if f liver metastases present); 13. Serum creatinine <=1.5 times ULN.

Exclusion criteria

Exclusion criteria: 1. Brain metastases with obvious symptoms; 2. Severe bone marrow failure and can not be corrected; 3. Chronic diarrhea history; 4. Bowel obstruction without control; 5. Mental illness without control; 6. Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension; 7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix; 8. Pelvic radiotherapy for the past 1 year; 9. Allergy to any of the components of the study medications; 10. With Serious, nonhealing wound or ulcer.

Design outcomes

Primary

Measure	Time frame
Toxicity related TTF;Incidence of side effects (Grade3 to 4);ORR;	—

Secondary

Measure	Time frame
OS;PFS;	—

Contacts

Public ContactXiang-Lin YUAN

yxl@medmail.com.cn+86 27 83663342

Outcome results

None listed

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