Preliminary efficacy of apatinib mesylate tablets in the treatment of unresectable hilar cholangiocarcinoma

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900022746

Enrollment

Unknown

Registered

2019-04-24

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Unresectable hilar cholangiocarcinoma

Interventions

experimental group:Apatinib mesylate

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, male and female; 2. Patients with cholangiocarcinoma confirmed by percutaneous biliary puncture biopsy or ERCP biopsy; 3. Patients who can not be resected surgically and have not received chemotherapy, radiotherapy or biliary stent implantation; 4. ECOG PS 0-2; 5. The main organs function normally and meet the following requirements: (1) Routine blood tests should be complied with (no blood transfusion within 14 days): A. Hb (> 90g/L); B. ANC (> 1.5 *10^9/L); C. PLT (> 80 *10^9/L); (2) Biochemical indicators should meet the following criteria: A. BIL < 1.5 times the upper limit of normal value (ULN) or transbiliary drainage (PTCD) reached this standard. B. ALT and AST < 2.5*ULN; ALT and AST < 5*ULN if liver metastasis occurs; C. Serum Cr < 1*ULN; 6. The estimated survival time is more than 3 months; 7. The patients joined the study voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pathologically confirmed patients with intrahepatic cholangiocarcinoma, gallbladder cancer and ampullary cancer; 2. Patients with hypertension who could not be reduced to normal range by antihypertensive drugs (SBP > 140 mmHg/DBP > 90 mmHg) suffered from coronary heart disease, arrhythmia and cardiac insufficiency of grade II or above. 3. There are many factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction). 4. Coagulation dysfunction (PT > 1.5 * ULN, APTT > 1.5 * ULN), with a tendency to bleed; 5. Symptomatic central nervous system metastasis.

Design outcomes

Primary

Measure	Time frame
Safety;	—

Secondary

Measure	Time frame
PFS;OS;ORR;DCR;	—

Countries

China

Contacts

Public ContactShi Baoqi

People's Hospital of Inner Mongolia Autonomous Region

592676401@qq.com+86 18604720008

Outcome results

None listed

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