Clinical trial · Interventional
A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Raltitrexed Plus Cetuximab
- description
- Raltitrexed Plus Cetuximab
- interventionNames
- Drug: Raltitrexed
- Drug: Cetuximab
Primary outcomes (2)
- measure
- The time from the beginning of first-line treatment until the disease progresses.
- timeFrame
- 24 months
- description
- Progression Free Survival 1.
- measure
- The time from the beginning of maintenance treatment until the disease progresses.
- timeFrame
- 24 months
- description
- Progression Free Survival 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available