Advanced metastatic colorectal cancer
Conditions
Interventions
rinotecan liposome combined with furoquininib:rinotecan liposome combined with furoquininib
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-75 (including) years old (on the day of signing the informed consent); 2.colorectal adenocarcinoma confirmed by histology or cytology; 3.patients with unresectable advanced colorectal cancer who had failed at least second-line standard chemotherapy and previous chemotherapy with irinotecan; 4.Each treatment line for advanced disease until disease progression included the use of one or more chemotherapy drugs for>=1 cycle; 5.Prior adjuvant/neoadjuvant therapy was allowed. First-line systemic chemotherapy was considered to have failed if recurrence or metastasis occurred during adjuvant/neoadjuvant therapy or within 6 months after completion of treatment. 6.Previous antineoplastic regimens, including chemotherapy, combined with targeted agents such as EGFR inhibitors (cetuximab or panitumumab, etc.) or VEGF inhibitors were permitted; 7.ECOG score 0-1; 8. the presence of at least one measurable target lesion according to RECIST v1.1 criteria; 9.Good bone marrow and organ function: (1) neutrophil (ANC) >=1.5×109/L, platelet (PLT) =100×109/L, hemoglobin (Hb) >=90 g/L, albumin (ALB) >=30 g/L, white blood cell (WBC) >=3.0×109/L, and no bleeding tendency; (2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) =40 ml/min (calculated by Cockroft-Gault); 10.Participants had expected survival of >= 3 months. 11.Women of childbearing age who had a negative serum pregnancy test within 7 days before randomization had to agree to use adequate contraception from the time they provided informed consent until 6 months after their last dose, when they are not lactating; Male participants had to agree to contraception and refuse to donate sperm. 12.fully understand the clinical trial and voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. participants with known central nervous system or meningeal metastases; 2.allergic to irinotecan or irinotecan liposome; 3. patients who underwent surgery within 5 weeks before enrollment and received other tumor treatment (including chemotherapy, radiotherapy, study treatment, etc.) within 4 weeks before enrollment; 4. Previous treatment with any VEGFR inhibitor (e.g., remifenib, remimuzumab, apatinib, axitinib, famitinib, or other tyrosine kinase inhibitor); 5. previous treatment-related toxicity did not recover to NCI-CTCAE v5.0 grade I or lower (except alopecia and peripheral neuropathy); 6. Use of a potent inhibitor or inducer of CYP3A, CYP2C8, and UGT1A1 (anticonvulsants [phenytoin, phenobarbitor, or carbamazepine], rifampicin, rifabutin, St.John's wort, grapefruit juice, clarithromycin, itraconazole, lopinavir, and nebide) could not be discontinued or not discontinued within 2 weeks before enrollment Fazodone, nelfinavir, ritonavir, Saquinavir, terapivir, voriconazole, azanavir, gefibrozil, indinavir, etc.); 7.severe gastrointestinal dysfunction (> NCI-CTCAE v5.0 grade I inflammation or diarrhea, etc.) or gastrointestinal perforation, intra-abdominal abscess or fistula; 8. patients with intestinal obstruction or symptoms and signs of intestinal obstruction, or patients with previous intestinal stent implantation and the intestinal stent was not removed until the screening period; 9.the presence of interstitial lung disease, except for interstitial changes on imaging; 10. Patients had arterial embolism or severe bleeding (except bleeding caused by surgery) within 6 months before enrollment or had the tendency of embolism or severe bleeding; 11. Patients with third-space effusion (such as massive pleural effusion, ascites and pericardial effusion) that could not reach a stable state (no intervention was needed after drainage tube removal), and those with only a small amount of ascites on imaging and without clinical symptoms could be enrolled. 12. Clinically significant electrolyte abnormalities; 13. dysphagia or known drug malabsorption; 14. stroke or transient ischemic attack occurred within 12 months before enrollment; 15. Incomplete healing of skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures; 16. acute myocardial infarction, severe/unstable angina, or coronary artery bypass graft surgery within 6 months before enrollment; Or patients with NYHA class 2 or above cardiac dysfunction; 17.severe psychological or mental disorders; 18. any severe or uncontrolled systemic illness, These include uncontrolled hypertension (defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg on standard antihypertensive medication), heart disease, active bleeding, active viral infections (including hepatitis B, hepatitis C [additional HBV DNA testing if either hepatitis B surface antigen or hepatitis B core antibody is positive], and hepatitis B virus infection. If HCV antibody is positive, HCV RNA should be tested, and HCV RNA should be excluded if it exceeds the maximum limit of our center], human immunodeficiency virus (HIV) infection), etc. 19. patients with other malignant tumors in the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer; 20. pregnant or lactating women, patients of childbearing age who refuse to accept contraceptive measures; 21. have participated in any other clinical trial within 4 weeks before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerable Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Disease control rate(DCR);Progression-free survival(PFS);Dose-limiting toxicity(DLT); | — |
Countries
China
Contacts
Public ContactLiao Xiaoli
Guangxi Medical University Cancer Hospital
Outcome results
None listed