advanced colorectal cancer
Conditions
Interventions
Experimental group:liposomal irinotecan+ raltitrexed+ fuquinitinib
Sponsors
The First Affiliated Hosptial of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Understand and be willing to sign written informed consent and be able to follow research protocols for treatment. 2.Age >=18 years old. 3.Patients with unresectable colorectal cancer confirmed by histopathology or cytopathology and whose imaging or pathological findings suggest local progression or distant metastasis (RAS, BRAF, and microsatellite instability (MSI)/mismatch repair (MMR) status must be recorded for each patient according to national guidelines). 4.The first line received oxaliplatin based therapy: a. One or more chemotherapeutic drugs used for >=1 cycle of first-line treatment until disease progression or toxicity becomes intolerable. b.Adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered a failure of first-line pre-systemic chemotherapy for advanced disease. 5.Participants with microsatellite high (MSI-H) or mismatch repair deficiency (dMMR) tumors must have been treated with an immune checkpoint inhibitor, unless the patient is not eligible for checkpoint inhibitor therapy. 6.No systematic chemotherapy or antitumor therapy such as radiotherapy, immunotherapy, biological or hormonal therapy in the past 4 weeks. 7.According to the RECIST v1.1 criteria, the patient hadat least one evaluable lesion. 8.ECOG performance status of 0-2. 9.Predicted survival time >= 3 months. 10.Adequate organ function; The definition is as follows: (Hematology and blood biochemistry examination should be completed within 14 days prior to enrollment, and the following conditions should be met) a. Absolute neutrophil count (ANC) >=1.5*10^9/L b. Hemoglobin >=90g/dL c. Platelets (PLT) >=100*10^9/L d. Total bilirubin = 50mL/min when serum creatinine>1 × ULN 11.Patients need to have proper nutritional status. 12.Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures. 13.No contraindications for the use of irinotecan liposomes, Rhatitrexed and fuquitinib.
Exclusion criteria
Exclusion criteria: 1.patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma. 2.Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment. 3.Intractable pleural effusion or ascites. 4.Any known brain or meningeal metastases. 5.Patients who have been co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing. 6.Patients who had large organ surgery (Except for needle biopsy, central venous catheterization, port catheterization, stent placement to relieve biliary obstruction, percutaneous transhepatic biliary drainage, and cholecystostomy) or an elective surgery program within 4 weeks before the first dose of the study drug. 7.Active infection: such as HIV infection, chronic HBV/HCV in the active phase (If HBV DNA has a copy number >= 10^4 or >= 2000IU/mL, antiviral and hepatoprotective treatment is required first. Only when HBV DNA has a copy number = 4 times per day compared to baseline; moderate to severe increase in fistula discharge; restricted daily activities). 14.Severe mental illness. 15.Known allergy to irinotecan liposomes, irinotecan, rhatitrexel, and fuquitinib related ingredients. 16.Had participated in other clinical investigators within 4 weeks prior to enrollment. 17.Women who are pregnant or breastfeeding, and patients of childbearing age who refuse to take appropriate contraceptive measures during the course of this trial. 18.The investigators evaluated patients who were not eligible to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DOR;TTF;QOL;safty; | — |
Countries
China
Contacts
Public ContactYao Yiwei
The First Affiliated Hosptial of Science and Technology of China
Outcome results
None listed