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Biweekly Raltitrexed Plus Oxaliplatin or Irinotecan to Treat Advanced CRC

A Multicenter Phase-II Study of Biweekly Raltitrexed Plus Oxaliplatin or Irinotecan as Second-line or Third-line in Advanced Colorectal Cancer Patients Pretreated With Fluoropyrimidines

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13004046
Enrollment
Unknown
Registered
2013-12-25
Start date
2013-12-02
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 colorectal cancer

Interventions

A:raltitrexed plus oxaplatin
B:raltitrexed plus Irinotecan

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of advanced colorectal cancer; 2. Measurable disease according to RECIST criteria version 1.1; 3. To be aged from 18 to 75 years; 4. ECOG performance score 12 weeks; 6. Hematologic function: N >=1.5*10^9/L, PLT >=80*10^9/L, Hb >=90mg/dL; 7. Renal function: within the normal limit; 8. Hepatic function: BIL <=1.5*UNL, ALT/AST <=2.5*UNL (<=5*UNL if accompanied with liver metastasis); 9. Documented informed consent to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breast feeding. Women of childbearing age must use effective contraception; 2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension); 3. pregnant or lactating woman; 4. Patient participation in other studies; 5. previously treated with raltitrexed; 6. previously treatment without Fluoropyrimidines; 7. uncontrolled brain metastasis.

Design outcomes

Primary

MeasureTime frame
resonse rate;

Secondary

MeasureTime frame
PFS;DCR;safety;

Countries

China

Contacts

Public ContactXu Nong

The First Affiliated Hospital of Zhejiang University

xunonghz@163.com+86 0571 56731277

Outcome results

None listed

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