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Anlotinib used for advanced intrahepatic cholangiocarcinoma with first-line treatment failure: a single-arm, open, exploratory study

Anlotinib used for advanced intrahepatic cholangiocarcinoma with first-line treatment failure: a single-arm, open, exploratory study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023475
Enrollment
Unknown
Registered
2019-05-30
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

advanced intrahepatic cholangiocarcinoma

Interventions

Sponsors

Kui Wang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 78 years, male or female; 2. Advanced intrahepatic cholangiocarcinoma patients received one first-line treatment failure; 3. ECOG score 0 or 1; 4. Expected survival> 12 weeks; 5. Swallow pills normally; 6. All patients should provide tumor tissue samples before enrollment to take the gene analysis (VEGFR1, VEGFR2, VEGFR3, FGFR, PDGFRß, c-Kit); 7. One lesion without receiving radiotherapy can be measured at least; 8. Organ function should meet the following requirement: Marrow: (ANC)=1.5×9E/L,PLT= 100×9E/L,HB=9g/dL; Liver:TBIL=1.5 times normal value,AST and ALT=2.5 times normal value;? Child-Pugh A; Cr=1.5 times normal value; INR and APTT =1.5 times normal value; UCG:LVEF >50%; 9. Non-pregnant women and Men and women with reproductive function use highly effective contraceptive methods; 10. The subjects volunteered to participate in the study and signed the informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients received anti-VEGFR TKI treatment; 2. Patients with central system metastasis; 3. Patients who have participated in or are participating in clinical trials of other drugs/therapies in late 4 weeks; 4. Patients who have received surgery and don't recover from the adverse effect in late 4 weeks; 5. Patients who are taking the immunosuppressant, or systemic hormone therapy for immunosuppressive purposes or taked this in 2 weeks; 6. Patients who have a history of malignant tumors other than ICC in the past 5 years; 7. Patients who received hematopoietic stimulating factors(G-CSF/EPO) within 1 week; 8. HIV antibody or treponema pallidum antibody test was positive; 9. Be allergic to anrotinib and any adjuvants; 10. Massive hydrothorax or ascites with clinical symptoms requiring symptomatic management; 11. The investigator determined that poor compliance or other conditions made the patient unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Countries

China

Contacts

Public ContactKui Wang

Eastern Hepatobiliary Surgery Hospital

wangkuiykl@163.com+86 13636330827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026