About this trial
To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have fully understood the study and voluntarily signed the informed consent;
Age ≥18 years old, gender unlimited;
Advanced metastatic colorectal adenocarcinoma confirmed by histopathology;
The patient progressed or was intolerant after receiving at least previous standard therapy containing fluorouracil, oxaliplatin, and irinotecan.
Disqualifiers
Previous treatment with Fruquintinib or other anti-vascular endothelial growth factor receptor (VEGFR) inhibitors such as Apatinib, Regorafenib, and Anlotinib;
Previous treatment with Raltitrexed;
Participated in other drug clinical trials and received at least one drug therapy within four weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks prior to enrollment;
The patient currently has a disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
Trial design
Single group
Treatments tested in this trial
Fruquintinib
DrugFruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death.
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival (PFS)
The time from enrollment to disease progression or death
Secondary outcomes
Objective response rate (ORR)
Proportion of patients with complete or partial response
Disease control rate (DCR)
Proportion of patients assessed as having a complete response, partial response, or stable disease
Overall survival (OS)
Patients were enrolled until their death from any cause
Security
Safety was evaluated by adverse reactions
Sponsors and contacts
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