Advanced Colorectal Cancer
Conditions
Brief summary
This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.
Interventions
DRUGAL2846
AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.
DRUGCalcium folate
Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle
DRUG5-FU
5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.
DRUGOxaliplatin
Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.
DRUGIrinotecan
Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-1. Histologically confirmed advanced metastatic colorectal cancer. 2. Has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed. 3\. At least one measurable lesion. 4. Has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks. 5.18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 6\. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form.
Exclusion criteria
* 1\. Diagnosed and/or treated additional malignancy within 5 years with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2\. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment. 3\. Has multiple factors that affect oral medications. 4. Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation. 5\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 6\. Has arterial or deep vein thrombosis events in 6 months. 7. Hypersensitivity to AL2846 or its excipient. 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 9\. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose. 10.Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin. 11\. Subjects plan to receive FOLFIRI chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant. 12\. Has drug abuse history that unable to abstain from or mental disorders. 13. Has any serious and/or uncontrolled disease. 14. Has received allogeneic organ transplants, hematopoietic stem cell transplants or bone marrow transplants. 15\. Has participated in other clinical trials within 4 weeks before the first dose. 16\. According to the investigators' judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 12 month | PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | up to 12 month | Percentage of participants achieving complete response (CR) and partial response (PR). |
| Disease control rate（DCR） | up to 12 month | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
| Duration of response (DOR) | up to 12 month | The time when the participants first achieved complete or partial remission to disease progression. |
Countries
China
Contacts
Primary ContactYunpeng Liu, Doctor
Outcome results
None listed