Metastatic colorectal cancer beyond progression on Fruquintinib monotherapy
Conditions
Interventions
experimental group:Fruquintinib plus 5-Fluorouracil /Leucovorin
Sponsors
National Center /Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with metastatic colorectal adenocarcinoma confirmed by histology; 2. Patients aged 18-70 years; 3. Patients with ECoG score of 0-1; 4. Patients who can swallow oral drugs; 5. Patients who have failed to receive fluorouracil (5-fluorouracil or capecitabine, tegio), oxaliplatin, irinotecan, bevacizumab, cetuximab (if Ras wild type) before entering the study were treated with fqtinib alone before entering the study, and the progression of the disease was evaluated by image, and the single treatment dose of fqtinib >= 4mg when entering the study; 6. Patients who are more than or equal to 7 days from the end of the last systematic treatment are allowed to receive palliative radiotherapy in the limited area for more than 4 weeks; 7. According to RECIST v1.1, there is at least one patient with measurable focus; 8. Patients with expected survival time >= 3 months; 9. For patients with sufficient organ and bone marrow functions, the laboratory test values within 7 days before enrollment meet the following requirements, as follows: (1) Blood routine test: absolute neutrophil count (ANC) >= 1.5 x 10^9 / L (for example, ANC 1.0-1.5 x 10^9 / L requires WBC >= 3.0 x 10^9 / L); platelet count (PLT) >= 100 x 10^9 / L; hemoglobin content (Hgb) >= 9.0 g / dl; (2) Liver function: TBIL = 50ml / min; urine routine test showed that urine protein = 2 + at baseline, 24-hour urine collection and 24-hour urine protein quantity = 50%; 11. Patients without other malignant tumor history, except for the cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, bladder epithelial tumor, simple surgical resection and cancer-free survival period >=5 years; 12. The pregnancy test of female subjects in childbearing age was negative, and effective and reliable contraceptive measures were taken voluntarily during the clinical trial; 13. Patients who fully understand the study, voluntarily participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients receiving other experimental drugs at the same time; 2. Patients with multiple factors (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.) affecting oral drugs; 3. Uncontrollable patients with pleural effusion, pericardial effusion or ascites requiring repeated drainage; 4. Patients with any physical signs or history of bleeding, regardless of severity; any bleeding event >= CTCAE within 4 weeks before the first administration Patients of grade 3; or patients with digestive tract diseases such as unhealed wound, fracture, gastric and duodenal active ulcer, ulcerative colitis, or patients with active bleeding due to unresected tumor, or other conditions that may cause serious gastrointestinal bleeding and perforation determined by researchers; 5. Patients who have received approved or under research anti-tumor treatment within 4 weeks before the start of study treatment, including but not limited to chemotherapy, surgery, radiotherapy (within 4 weeks), biological target treatment, interventional treatment, immunotherapy and anti-tumor traditional Chinese medicine treatment (subject to indications in the manual of traditional Chinese medicine, if they can also be included in the group after 2 weeks of washout period), etc. (Note: oral fluorouracil drugs are less than 14 Days; the adverse events (except hair loss) caused by previous treatment did not recover to = 480ms); (3) Active or uncontrolled severe infection (>= CTC AE Level 2 infection); (4) The patients with known clinical history of liver disease, including viral hepatitis, who are known to be carriers of hepatitis B virus (HBV) must be excluded from active HBV infection, that is, HBV DNA positive (> 1 x 10^4 copies / ml or > 2000 IU / ml); known hepatitis C virus infection (HCV) and HCV RNA positive (> 1 x 10^3 copies / ml), Or other decompensated liver disease, chronic hepatitis need to receive antiviral treatment; (5) HIV positive; (6) In the opinion of the investigator, the subject has any clinical or laboratory abnormality and is not suitable to participate in the clinical study, or the compliance of participating in the clinical study is insufficient; (7) Serious allergic reaction to the test drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recommended phase 2 dose (RP2D);6-month overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events rates;dose limited toxicity;maximal tolerable dose;progression-free survival;overall survival;objective response rate;disease control rate;The prognosis or monitoring values of circulating tumor cells;The prognosis or monitoring values of lymphocyte subsets count;Pharmacogenomics analyses; | — |
Countries
China
Contacts
Public ContactLin Yang
Cancer Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed