Second-line Treatment of Metastatic Colorectal Cancer
The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the me
| Condition(s) | Metastatic Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence. |
| Who can participate | Inclusion Criteria: 1. All subjects are required to sign an informed consent form before starting the study-related procedure 2. Age 18-75 years old, male or female. 3. have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, life expectancy \>3 months. 4. Histologically or cytological proven metastatic or recurrent adenocarcinoma of the colon or rectum. 5. Prior treatment with a fluoropyrimidine (5-fluorouracil \[5-FU\] or capecitabine) and oxaliplatin with bevacizumab or cetuximab targeted therapy as the first-line regimen. 6. Recurrence or metastasis within 12 months after completion of adjuvant/neoadjuvant therapy with oxaliplatin and fluoropyrimidine-based drugs is also considered as the failure of first-line chemotherapy. 7. At least one measurable metastatic le |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Jinan, Shandong, China |
| Start date | 2023-04-23 |
| NCT ID | NCT06242067 |
| Official listing | https://clinicaltrials.gov/study/NCT06242067 |