CholangiocarcinomaPhase 2NCT07619937
Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma
A Phase 2 study testing HAIC Combined with Tislelizumab and Regorafenib in people with Cholangiocarcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- HAIC Combined with Tislelizumab and Regorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2022to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 ;
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- Hypersensitivity to contrast agents or study drugs ;
- Pregnancy or lactation;
- Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: 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 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:
Read more
- 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- HAIC Combined with Tislelizumab and Regorafenib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC Combined with Tislelizumab and RegorafenibDrug
A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| HAIC combined with tislelizumab and regorafenib | Experimental | Not described Receives: Drug: HAIC Combined with Tislelizumab and Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Measured: From first dose until disease progression, death, or up to approximately 24 months
Secondary outcomes (4)
disease control rate (DCR)
Measured: From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)
Progression-Free Survival (PFS)
Measured: From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
Measured: From first dose to death from any cause (up to approximately 36 months)
adverse events
Measured: From first dose until 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start22 Jul 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhen li, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619937
- Sponsor's protocol ID
- ChiECRCT20220109
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07619937
- Acronym / sponsor ID
- ChiECRCT20220109
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC combined with tislelizumab and regorafenib | Experimental | Drug: HAIC Combined with Tislelizumab and Regorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 ;
Key exclusion criteria (9 listed)
- Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
- Prior antitumor treatment ;
- Concurrent primary malignancies;
- Child-Pugh class C;
- Severe cardiac, pulmonary, or renal dysfunction ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAIC Combined with Tislelizumab and RegorafenibA combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma. | Drug | HAIC combined with tislelizumab and regorafenib |
Primary outcome
objective response rate (ORR)
Time frame: From first dose until disease progression, death, or up to approximately 24 months
4 secondary outcomes
disease control rate (DCR)
Time frame: From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)
Progression-Free Survival (PFS)
Time frame: From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
Time frame: From first dose to death from any cause (up to approximately 36 months)
adverse events
Time frame: From first dose until 30 days after the last dose of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAIC Combined with Tislelizumab and Regorafenib in people with Cholangiocarcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: From first dose until disease progression, death, or up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.