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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    698
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 28 August 2021

Summary

This is an open label, randomized, phase study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.

Details
Condition Metastatic Colorectal Cancer
Treatment Capecitabine, bevacizumab, Oxaliplatin, Anlotinib hydrochloride capsule
Clinical Study IdentifierNCT04854668
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on28 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1Life 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

Has dMMR/MSI-H. 2. Combined with the following diseases or medical history
Previous or co-existing malignancies within 3 years except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors
Has many factors that affect the oral administration of drugs
Has Gastrointestinal bleeding or perforation within 4 weeks before the first dose
Has active inflammatory bowel disease within 4 weeks before the first dose
Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
Patients whose adverse events (except hair loss) caused by previous treatment did not recover to CTCAE 1 degree
Has received major surgical procedurebiopsy or obvious traumatic injury within 28 days before the first dose
Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary of blood vessels is unclear
Has any bleeding event or the level of bleeding events CTCAE 3
Has unhealed wounds, ulcerative or fractures
Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
Has a history of psychotropic substance abuse and are unable to quit
Has any severe and / or uncontrolled disease 3.Tumor related symptoms and treatment
Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose
Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose
Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs
Has received systematic treatment for advanced colorectal cancer
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
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