NCT07619937CompletedPhase 2
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
The First Affiliated Hospital of Zhengzhou University1 site in 1 country31 target enrollmentStarted: July 22, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
Study Overview
Brief Summary
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:
- What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
- •Prior antitumor treatment ;
- •Concurrent primary malignancies;
- •Child-Pugh class C;
- •Severe cardiac, pulmonary, or renal dysfunction ;
- •Active autoimmune disease or need for long-term immunosuppressive therapy ;
- •Hypersensitivity to contrast agents or study drugs ;
- •Pregnancy or lactation;
- •Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.
Investigators
zhen li
Department of Interventional Radiology
The First Affiliated Hospital of Zhengzhou University
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence FactorsNCT07337421Northern Jiangsu People's Hospital30
Not yet recruiting
Phase 2
Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver MetastasesColorectal Cancer Liver Metastases (CRLM)Liver MetastasisColorectal CancerNCT07570914Tianjin Medical University Cancer Institute and Hospital28
Active, not recruiting
Not Applicable
HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary InvasionNCT07466225Peking University150
Terminated
Phase 1
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic CholangiocarcinomaLiver NeoplasmsCholangiocarcinomaNCT01525069Washington University School of Medicine27
Enrolling By Invitation
Phase 1
Safety, Tolerability, and Preliminary Efficacy of Hepatocyte-like Cell Injection for the Prevention and Treatment of Small-for-Size SyndromeSmall-for-size SyndromeAcute Liver FailureChronic Liver FailureNCT07276568Zhi-Jun Zhu12