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Phase II study for bevacizumab combined with S-1 and raltitrexed in the treatment of metastatic colorectal cancer resistant to 5-fluorouracil / oxaliplatin /irinotecan

Phase II study for bevacizumab combined with S-1 and raltitrexed in the treatment of metastatic colorectal cancer resistant to 5-fluorouracil / oxaliplatin /irinotecan

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020485
Enrollment
Unknown
Registered
2019-01-02
Start date
2015-09-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

metastatic colorectal cancer

Interventions

Case series:bevacizumab combined with S-1 and raltitrexed

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Pathologic diagnosis confirming, metastatic colorectal adenocarcinoma. 2) Aged at least 18 years old male and female; 3) Expected survival more than 12 weeks; 4) ECOG PS score was 0-2; 5) Failure of 5-fluorouracil (or capecitabine), oxaliplatin and irinotecan; 6) no use of Raltitrexed or S-1 in the treatment of metastatic colorectal cancer; 7) Bevacizumab has never been used or used only once in the previous chemotherapy regimen before enrollment. 8) Patients were at least 2 weeks after the last chemotherapy or 4 weeks after the end of radiotherapy, and the lesions were observed in the non-radiotherapy target area in this study 9) According to the RECIST1.1, at least one measurable lesion:spiral CT examination, its maximum diameter must be more than 1cm; ordinary CT or MRI, and its maximum diameter must be more than 2cm; 10) adequate bone-marrow, liver, and renal function: Hemoglobin more than 90g/L; Platelets (PLT) more than 75 x 10^9/L; White blood cell (WBC) more than 3 x 109/L; neutrophils (ANC) more than 1.5 x 10^9/L; Total bilirubin (TBI) less than 1.5 x normal upper limit (UNL); Serum creatinine (Cr) less than 1.5 x upper limit of normal value. Glutamic pyruvic transaminase (ALT) and aspartate aminotransferase (AST) less than 2.5 x UNL(if liver metastases less than 5 x UNL); 11) Patients volunteered to participate in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe hepatorenal insufficiency or recent myocardial infarction (within 3 months); 2) With other malignancy history in 5 years (except for basal cell carcinoma of the skin and in situ cervical cancer); 3) With brain metastases or nervous system oppressors; 4) Serious uncontrolled internal diseases or acute infections (fever caused by infection over 38 degrees); 5) Serious internal and external diseases affect organ function; 6) Pregnant women or lactating women or those with fertility (men or women who are less than 1 years' menopause) are unwilling to take contraceptive measures; 7) With a history of chronic diarrhea or complete intestinal obstruction; 8) Underwent major surgery within the first 28 days of admission; 9) Take aspirin regularly (over 325mg/ days) or other non steroidal anti-inflammatory drugs; 10) Patients who had bleeding tendency, coagulopathy or need full dose anticoagulation therapy; 11) Known to be allergic to bevacizumab or Raltitrexed or S-1 and its components; 12) The researchers judged patients who were not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactHong-Feng Gou

Department of Abdominal Oncology,West China Hospital of Sichuan University

joan_gou1977@163.com+86 18980602292

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026