A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer

• Status: Recruiting
• Trial end date: 2021-11-28
• Target enrollment: 0
• Participant gender: All

Summary

Maintenance treatment can extend patient survival and improve patient quality of life. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. In contrast, there are little datas of cetuximab as a maintenance treatment. The purpose of this study is to evaluate efficacy and safety of Raltitrexed plus Cetuximab as the maintenance treatment, and to provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Cancer Institute & Hospital
• Treatments: Cetuximab; Raltitrexed

Criteria

Inclusion Criteria:

• 18-75 years old, no gender restriction;

• RAS wild-type

• Unresectable metastatic colorectal cancer confirmed by histopathology and / or cytology;

• Disease stable or improved while on first-line use of FOLFOX/FOLFIRI with cetuximab for 4-6 months;

• At least one measurable objective tumor lesion by spiral CT scan，the longest diameter measured ≧ 10 mm，or by conventional CT scan，the diameter measured ≧ 20 mm.

• Eastern Cooperative Oncology Group (ECOG) general status score is 0-2;

• Life expectancy of at least 3 months;

• Blood routine, liver and kidney function within the 7 days before screening meet the following criteria: Absolute neutrophil count ≥ 1.5x10^9 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x10^9 / L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN (≤5 x ULN in patients with liver metastases); ≤3 x ULN in patients with liver metastases (≤5 x ULN in patients with liver metastases); serum creatinine ≤1.5 x ULN;

• Agree to sign informed consent.

Exclusion Criteria:

• BRAF mutant

• Symptomatic brain or meningeal metastases (unless patients receive treatment> 6 months, imaging results are negative within 4 weeks before joining the study, and tumor-related clinical symptoms are stable before joining the study);

• Previous malignant disease within five years, with the exception of the cured primary cervical cancer or basal cell carcinoma of the skin;

• Chronic intestinal disease, infectious intestinal disease, intestinal obstruction, active clinical severe infection and other diseases;

• With ascites

• Substance abuse and medical, psychological or social conditions that may interfere with the participation of patients in the study or influence the evaluation of the results of the study;

• Unsuitable for the study or other chemotherapy determined by investigator.