Status:
COMPLETED
Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Colorectal Cancer
RAS and BRAF Wild-type
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CR...
Detailed Description
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CR...
Eligibility Criteria
Inclusion
- At least one measurable lesion (the length of spiral CT scan (\> 10mm) meets the requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria.
- ≥ 18 and ≤ 75 years of age
- ECOG performance status of 0-1
- No prior treatment for advanced disease (adjuvant therapy allowed)
- Life expectancy of at least 3 months
- The main organs are functioning normally.
- Neutrophils count =/\> 1.5 x 109/L, platelets count =/\> 100 x 109/L, HGB =/\> 90 g/L
- total bilirubin =/\< 1.5 x UNL • SGOT and SGPT =/\< 2.5 x UNL (=/\< 5 x UNL in patients with liver metastases)
- Creatinine =/\< 1.5 x UNL
- Patients who are molecularly diagnosed as having RAS and BRAF wild-type mCRC are Histologically/cytologically confirmed as advanced, colorectal cancer.
- Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion
- Pregnant or lactating women.
- Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
- Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg), patients with myocardial infarction, arrhythmias with poor control (including QTC interval \> 450 ms) and cardiac insufficiency of grade II according to NYHA standard.
- with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.
- serious uncontrolled intercurrence infection.
- Proteinuria ≥ 2+ (1.0g/24hr).
- Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness.
- Within 6 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
- Have a history of mental illness or psychotropic drug abuse.
- Patients with a history of immunodeficiency(or autoimmue disease), or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation.
- Patients who are allergic to components of Capecitabine preparations, Oxaliplatin injection and anlotinib preparations.
- According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.
- Patients who have received prior systemic chemotherapy, targeted therapy, immunity therapy or any medication within 30 days.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04080843
Start Date
November 15 2019
End Date
July 1 2022
Last Update
July 13 2022
Active Locations (2)
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1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China