NCT06239532Active, not recruitingPhase 2
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 28 Dec 2023
- Start date
- 27 Sept 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06239532
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 28
- From 27 Sept 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).
Other illness
- History of hepatic encephalopathy or liver transplantation.
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
Other
- Recurrent patients.
- Eastern Cooperative Oncology Group performance status ≥ 2.
- Life expectancy of less than 3 months.
- Child-Pugh classification score \> 8.
- Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
- Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
- The researcher considers it inappropriate to enter this study.
Who the study is looking for
- Written informed consent for the trial.
- Aged ≥18 years.
- Histologically confirmed intrahepatic cholangiocarcinoma.
- No other previous systematic treatment for BTC.
- At least one measurable lesion (RECIST 1.1).
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Life expectancy of 3 months or greater.
- Child-Pugh classification score ≤7.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.