NCT07619937CompletedPhase 2
Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma
Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma: A Single-Centre, Single-Arm, Phase II Trial
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and regorafenib as first-line therapy in patients with locally advanced or metastatic cholangiocarcinoma. The main questions it aims to answer are: 1. What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria 2. What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment Participants will:Receive hepatic arterial infusion chemotherapy (HAIC)+ tislelizumab (PD-1 inhibitor)+regorafenib (oral multikinase inhibitor). Undergo regular imaging assessments to evaluate tumor response per RECIST 1.1.Be monitored for survival outcomes and adverse events throughout treatment and follow-up.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 27 May 2026
- Start date
- 22 Jul 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07619937
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 22 Jul 2022 to the primary completion date, 30 Sept 2025
- 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
- Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
- Prior antitumor treatment ;
- Concurrent primary malignancies;
- Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.
Other illness
- Severe cardiac, pulmonary, or renal dysfunction ;
- Active autoimmune disease or need for long-term immunosuppressive therapy ;
- Hypersensitivity to contrast agents or study drugs ;
Other
- Child-Pugh class C;
- Pregnancy or lactation;
Who the study is looking for
- Age 18-75 years ;
- Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ;
- Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ;
- No prior antitumor therapy;
- Child-Pugh liver function class A or B ;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- At least one measurable lesion per RECIST 1.1 ;
- Adequate haematologic and hepatic/renal function;
- Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ;
- Adequate cardiac and pulmonary reserves to tolerate interventional procedures ;
- Signed informed consent, good compliance, and ability to attend follow-up visits.
Age in the registry: 18 years to 75 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 |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.