A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Apr 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with metastatic colorectal cancer that has certain genetic characteristics known as RAS/BRAF wild-type. The researchers want to see if combining a medication called Anlotinib with standard chemotherapy (CapeOx and Bevacizumab) can help patients more effectively than chemotherapy alone. Participants will be randomly assigned to receive either the new combination treatment or the standard treatment.

To be eligible for this study, participants should be between the ages of 18 and 75, have confirmed metastatic colorectal cancer that cannot be surgically removed, and have at least one measurable tumor. They should also be in overall good health, with a life expectancy of at least three months. Participants can expect to receive treatment for a set period and will be monitored closely for any side effects and the effectiveness of the treatment. It’s important to note that pregnant or breastfeeding women cannot participate, and there are specific health conditions that would exclude someone from joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy≥ 3 months.
• • 3. Histologically or cytologically confirmed unresectable metastatic colorectal cancer.
• • 4. Has RAS/BRAF wild-type. 5. Has at least one measurable lesion. 6. Adequate organ function. 7.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
• Exclusion Criteria:
• * 1.Has dMMR/MSI-H. 2. Combined with the following diseases or medical history:
• • 1. Previous or co-existing malignancies within 3 years except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors；
• • 2. Has many factors that affect the oral administration of drugs；
• • 3. Has Gastrointestinal bleeding or perforation within 4 weeks before the first dose；
• • 4. Has active inflammatory bowel disease within 4 weeks before the first dose；
• • 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage；
• • 6. Patients whose adverse events (except hair loss) caused by previous treatment did not recover to ≤CTCAE 1 degree；
• • 7. Has received major surgical procedure、biopsy or obvious traumatic injury within 28 days before the first dose；
• • 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary of blood vessels is unclear；
• • 9. Has any bleeding event or the level of bleeding events ≥ CTCAE 3；
• • 10. Has unhealed wounds, ulcerative or fractures；
• • 11. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism；
• • 12. Has a history of psychotropic substance abuse and are unable to quit ；
• • 13. Has any severe and / or uncontrolled disease； 3.Tumor related symptoms and treatment
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• • 1. Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose.
• • 2. Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose.
• • 3. Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs.
• • 4. Has received systematic treatment for advanced colorectal cancer.
• • 5. Has symptomatic brain metastases or control of symptoms \< 2 month. 4.Has participated in other anticancer drug clinical trials within 4 weeks. 5.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.