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Clinical study of temperature-sensitive loading medicine gel in intrahepatic cholangiocarcinoma

Clinical application research of Temperature-sensitive drug-loaded gel hepatic artery embolization in intrahepatic cholangiocarcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105380
Enrollment
Unknown
Registered
2025-07-02
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Intrahepatic cholangiocarcinoma, ICC

Interventions

Control group:Xelox regimen chemotherapy alone
Group B:cTACE (iodized oil mixed oxaliplatin) Xelox regimen chemotherapy
Group A:tsTACE (oxaliplatin-loaded thermosensitive gel) Xelox regimen chemotherapy

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-80 years old, with an estimated survival time of >=3 months; 2.Sign the informed consent form; 3.The pathology of the liver lesion was clearly cholangiocarcinoma; 4.Those who have failed or are intolerant to first-line GC chemotherapy; 5.There are no indications for radical surgical operation or the operation is refused; 6.There are no serious organ dysfunction or failure; 7.The Child pugh score of liver function is <=8 points, and the ECOG physical strength score is <=2 points; 8.No other anti-tumor treatment was performed within 4 weeks before enrollment; 9.In contrast-enhanced MRI images, there is at least one lesion that can be measured according to the mRECIST standard.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women; 2.Those who are allergic to the test drug or contrast agent; 3.Those with severe organ dysfunction or failure and cachexia; 4.Those with severe cardiovascular and cerebrovascular diseases that have not been effectively controlled, or those whose mental disorders have affected the therapeutic effect; 5.It has indications for radical surgical treatment; 6.Child pugh of liver function > 8 points; 7.Hemoglobin 10*10^9/L, grade 2 or above bone marrow suppression or severe infection signs, platelets 50ml/min; 8.Arterial malformations make intubation impossible or are not suitable for interventional treatment due to severe jaundice, cancerous ascites, etc; 9.Had received anti-tumor treatment or participated in other clinical trials within 4 weeks before enrollment.

Design outcomes

Primary

MeasureTime frame
OS;Objective response rate, ORR;Disease contral rate, DCR;

Countries

China

Contacts

Public ContactJun Luo

Zhejiang Cancer Hospital

bjy0927@163.com+86 571 88122441

Outcome results

None listed

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