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A single-arm prospective study of biliary stent placement combined with icaritin and GS in the treatment of cholangiocarcinoma with obstructive jaundice

A single-arm prospective study of biliary stent placement combined with icaritin and GS in the treatment of cholangiocarcinoma with obstructive jaundice

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072482
Enrollment
Unknown
Registered
2023-06-14
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Cholangiocarcinoma

Interventions

Trial Arm:Icaritin in combination with gemcitabine and S-1

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Contrast-enhanced CT or MRCP confirmed the presence of biliary stricture, which was pathologically confirmed to be malignant or was supported by clinical evidence of malignant obstruction caused by cholangiocarcinoma; 2. Age range from 18 to 80 years old, both male and female; 3. After biliary stent placement, biliary angiography proved that the biliary tract was unobstructed; 4. The general condition was good, and the Karnofsy score within 1 week before enrollment was =60 points; 5. ECOG score =2; 6. The patients signed an informed consent form agreeing to participate in the study and were guaranteed follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Combined with severe cardiopulmonary dysfunction, unable to tolerate biliary stent surgery; 2. Combined with other malignant tumors other than biliary stricture; 3. The biliary tract was not unobstructed by cholangiography at 1 week after biliary stent placement; 4. ECOG score =3; 5. Distant metastasis; 6. Patients with mental disorders; 7. Icaritin drug intolerance; 8. People who are participating in clinical trials of other drugs or receiving other treatments; 9. Other reasons were considered by the investigators to be inappropriate for clinical trials.

Design outcomes

Primary

MeasureTime frame
Time of biliary restenosis;

Secondary

MeasureTime frame
Overall Survival;Time to deterioration of quality of life;

Countries

China

Contacts

Public ContactYuliang Li

The Second Hospital of Shandong University

lyl.pro@sdu.edu.cn+86 135 7378 0666

Outcome results

None listed

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