Apatinib (Aitan) in patients with recurrent and metastatic intrahepatic cholangiocarcinoma: phase II clinical study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034166

Enrollment

Unknown

Registered

2020-06-27

Start date

2018-03-01

Completion date

Unknown

Last updated

2020-06-29

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

Conditions

Recurrent/metastatic intrahepatic cholangiocarcinoma

Interventions

Case series:Apatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age: 18-75 years old; 2) Pathologically confirmed intrahepatic cholangiocarcinoma in our hospital; 3) Received at least one local treatment (surgery, intervention, ablation, etc.) and was determined the progress of the disease; 4) Recurrence or metastasis of ICC confirmed by imaging, at least one target lesion that can be evaluated according to RECIST criteria; 5) ECOG 0-1 point; 6) Child-Pugh Class A; 7) WBC >3×10E9/L; HB >90 G/L; PLT >50×10E9/L; 8) ALT, AST does not exceed the 2.5 times of upper limit of the normal value; CRE, TBIL does not exceed the 1.5 times of upper limit of the normal value; 9) The patient agrees to join the study and follow up regularly as required by the study, signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Risk of tumor rupture; 2) Patients after organ transplantation; 3) Receive other anti-tumor treatments (such as TACE, chemotherapy, radiotherapy, etc.) and immune cell infusion therapy at the same time; 4) Uncontrolled cardiovascular and cerebrovascular diseases, poor blood pressure control (>150/90mmHg); 5) History of gastrointestinal bleeding within 6 months; 6) History of kidney disease or systemic immune diseases; 7) Active infections other than HBV and HCV; 8) There are comorbidities, and it is not advisable to take apatinib (such as bile leakage requires long-term drainage tube, poor wound healing, etc.); 9) Clear history of peptic ulcer; 10) Poor compliance, can not insist on regular follow-up; 11) Merged with other malignant tumors; 12) Sever heart, lung, kidney, and brain diseases.

Design outcomes

Primary

Measure	Time frame
Progression-free Survival;	—

Secondary

Measure	Time frame
Objective response rate;Disease control rate;Overall survival;safety;	—

Countries

China

Contacts

Public ContactLi Xu

Sun Yat-sen University Cancer Center

xuli@sysucc.org.cn+86 020 87343582

Outcome results

None listed

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