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

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ClinicalTrials.gov Identifier: NCT04854668
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
This is an open label, randomized, phase Ⅲ 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Anlotinib hydrochloride capsule Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anlotinib + CapeOx
Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine.
 Drug: Anlotinib hydrochloride capsule
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；

Drug: Oxaliplatin
Oxaliplatin 130mg/m2, intravenous drip, on Day 1；

Drug: Capecitabine
Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.
Active Comparator: Bevacizumab + CapeOx
Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine.
 Drug: Bevacizumab
Bevacizumab 7.5mg/kg, intravenous drip, on Day 1

Drug: Oxaliplatin
Oxaliplatin 130mg/m2, intravenous drip, on Day 1；

Drug: Capecitabine
Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) assessed by IRC [ Time Frame: Baseline up to 15 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Baseline up to 15 months ]
    PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.

  2. Overall survival (OS) [ Time Frame: Baseline up to 20 months ]
    OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

  3. Objective Response Rate（ORR） [ Time Frame: Baseline up to 15 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) .

  4. Disease Control Rate (DCR) [ Time Frame: Baseline up to 15 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

  5. Duration of Response (DOR) [ Time Frame: Baseline up to 15 months ]
    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854668


Locations
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China, Anhui
Fujian Medical University Union Hospital Recruiting
Fuzhou, Anhui, China, 350011
Contact: Xiaoyan Lin, Doctor    13365910793    xiaoyanlin@yahoo.com   
Principal Investigator: Xiaoyan Lin, Doctor         
Anhui Provincial Hospital Recruiting
Hefei, Anhui, China, 230001
Contact: Yueyin Pan, Doctor    0551-62283114    yueyinpan@126.com   
Principal Investigator: Yueyin Pan, Doctor         
China, Fujian
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350011
Contact: Rongbo Lin    13705919382    rongbo_lin@163.com   
Principal Investigator: Rongbo Lin         
China, Gansu
Gansu Provincial Cancer Hospital Recruiting
Lanzhou, Gansu, China, 730000
Contact: Xiaoning Zhao, Master    0931-2603485    zxn63@sina.com   
Principal Investigator: Xiaoning Zhao, Master         
China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Kefeng Ding, Doctor    0571-87784720    dingkefeng@zju.edu.cn   
Principal Investigator: Kefeng Ding, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04854668    
Other Study ID Numbers: ALTN-Ⅲ-02
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
 Capecitabine
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action