Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma

NCT07619937 | Completed Phase 2

• 1 other identifier: ChiECRCT20220109
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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:

1. 1.What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria
2. 2.What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  From first dose until disease progression, death, or up to approximately 24 months

Secondary Outcomes (4)

• disease control rate (DCR)

  From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)

• Progression-Free Survival (PFS)

  From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

• Overall Survival (OS)

  From first dose to death from any cause (up to approximately 36 months)

• adverse events

  From first dose until 30 days after the last dose of study treatment

Study Arms (1)

HAIC combined with tislelizumab and regorafenib

EXPERIMENTAL

Drug: HAIC Combined with Tislelizumab and Regorafenib

Interventions

HAIC Combined with Tislelizumab and Regorafenib DRUG

A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.

HAIC combined with tislelizumab and regorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

tislelizumab; regorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Interventional Radiology

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: July 22, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (1)