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First-Line XELOX Plus Anlotinib Followed by Single-Agent Anlotinib as Maintenance Therapy in mCRC Patients

First-Line XELOX Plus Anlotinib Hydrochloride Followed by Single-Agent Anlotinib Hydrochloride as Maintenance Therapy in Patients with Metastatic Colorectal Carcinoma: An Open, Single Arm, Multicenter, Exploratory Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028417
Enrollment
Unknown
Registered
2019-12-21
Start date
2019-12-20
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

Interventions

Case series:Anlotinib+XELOX

Sponsors

Sichuan Cancer Hospital and Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. At least one measurable lesion (the length of spiral CT scan (> 10mm) meets the requirements of RESCIST 1.1) is found in patients with mCRC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria; 2. Aged 18 to 75 years; 3. ECOG performance status of 0-1; 4. No prior treatment for advanced disease (adjuvant therapy allowed); 5. Life expectancy of at least 6 months; 6. The main organs are functioning normally; 7. Neutrophils count =/> 2.0x10^9/L, platelets count =/> 80x10^9/L, HGB =/> 90 g/L; 8. total bilirubin =/< 1.5 UNL; 9. SGOT and SGPT =/< 2.5 UNL (=/< 5 UNL in patients with liver metastases); 10. Creatinine =/< 1.5 UNL; 11. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments; 3. 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 =/> 480 ms) and cardiac insufficiency of grade II according to NYHA standard; 4. with bleeding tendency or undergoing thrombolysis or anticoagulation therapy; 5. serious uncontrolled intercurrence infection; 6. Proteinuria >=2+ (1.0g/24hr); 7. Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness; 8. Within 6 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.; 9. Have a history of mental illness or psychotropic drug abuse; 10. Patients with a history of immunodeficiency, or other acquired congenital immunodeficiency diseases, or a history of organ transplantation; 11. Patients who are allergic to components of Capecitabine preparations, Oxaliplatin injection and Anlotinib preparations; 12. According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
ORR;DOR;DCR;Safety;

Countries

China

Contacts

Public ContactJin Yan

Sichuan Cancer Hospital and Research Institute

yanjin_1111@163.com+86 18908178898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026