Advanced Colorectal Carcinoma
Conditions
Keywords
advanced colorectal cancer, fruquintinib, raltitrexed, target therapy
Brief summary
A randomized, controlled phase II clinical trial of Fruquintinib combined with Raltitrexed versus Fruquintinib monotherapy in patients with advanced colorectal cancer who had failed second-line or above standard chemotherapy
Detailed description
This study plans to evaluate the clinical benefits of fruquintinib combined with raltitrexed compared with fruquintinib single drug treatment in patients with advanced colorectal cancer who have failed second-line or above treatment, in order to explore the rationality of this strategy with chemotherapy + targeted combination therapy and obtain the relevant survival and safety data. A total of 136 patients were planned to be enrolled in this study.
Interventions
DRUGFruquintinib and raltitrexed
Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w
DRUGFruquintinib
Fruquintinib 5mg qd monotherapy
Sponsors
Shanxi Province Cancer Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is an open-label, randomized, controlled, multi-centered phase II clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. no less than 18 years old 2. confirmed by histopathological examination, recurrent/metastatic colorectal adenocarcinoma 3. had received at least two lines standard chemotherapy and failed. These standard regimens must include fluorouracil, oxaliplatin, and irinotecan. Treatment failure was defined as disease progression within 3 months after the last treatment or intolerance of toxicity or side effects during treatment ; Note: A. each line of treatment shall include more than one cycle of chemotherapeutic agents; B. adjuvant/neoadjuvant therapy is allowed in the former treatment. If recurrence or metastasis occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for the advanced disease; C. Prior antitumor therapy regimens using chemotherapy combined with cetuximab or bevacizumab were permitted. 4. with one or more measurable lesions, according to RECIST criteria, version 1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance score(PS) from 0 to 2; 6. Life expectancy no less than 12 weeks; 7. Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood neutrophil count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin \< 1.5 x upper normal limit（UNL), alanine aminotransferase（ALT） and aspartate transaminase（AST）\< 2.5 x UNL(\< 5 x UNL for patients with live metastasis), serum creatinine≤1 x UNL，endogenous creatinine clearance rate \>50ml/min 8. Women of reproductive age need to take effective contraceptive measures. 9. Participate in this study voluntarily and sign informed consent. Understand the purpose of this study and the necessary procedures. Good compliance to cooperate with the follow-up.
Exclusion criteria
1. urine protein 2 + or above, or 24 hours urinary protein quantitative acuity 1.0 g / 24 h 2. Abnormal coagulation function or those receiving thrombolytics or anticoagulants 3. Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months 4. Received other systemic anti-tumor therapy, including cell signal transduction inhibitors, drug therapy, immune therapy within 3 weeks 5. With uncontrolled high blood pressure (systolic blood pressure \> 140 MMHG, diastolic blood pressure \> 90 MMHG) 6. Radiotherapy therapy for target lesions 7. symptomatic cerebral or meningeal metastasis; 8. Uncontrolled pleural or peritoneal effusion 9. Undergoing dialysis 10. Severe or uncontrolled infection 11. With multiple factors that affecting oral administration 12. Former exposed to any VEGFR tyrosine kinase inhibitors (e.g regorafenib, apatinib, anlotinib etc.) for treatment 13. Raltitrexed treatment for more than one cycle in former line therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | assessed up to 24 months | the time from randomization to tumor progression or death from any cause,whichever came first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | assessed up to 36 months | the time from randomization to death from any cause,whichever came first, |
| objective response rate (ORR) | through study completion, an average of 2 year | The proportion of patients whose tumors shrink to a certain extent and remain constant for a certain period of time |
| disease control rate (DCR) | through study completion, an average of 2 year | Percentage of cases with response to treatment (PR+CR) and disease stability (SD) that can be evaluated |
Other
| Measure | Time frame | Description |
|---|---|---|
| quality of life score (QOL) | through study completion, an average of 2 year | EORTC QOL-C30, version 3.0, |
Countries
China
Contacts
Primary ContactChenchen Wang
Outcome results
None listed