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Intrahepatic CholangiocarcinomaPhase 2NCT06239532

HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

A Phase 2 study testing HAIC+TAE, Tislelizumab and Surufatinib in people with Intrahepatic Cholangiocarcinoma, run by Qilu Hospital of Shandong University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
HAIC+TAE, Tislelizumab and Surufatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
27 Sep 2022to 31 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Recurrent patients.
  • Eastern Cooperative Oncology Group performance status ≥ 2.
  • Life expectancy of less than 3 months.
  • Child-Pugh classification score > 8.
  • History of hepatic encephalopathy or liver transplantation.
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
Show all 11Show fewer
  • 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.
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).
  • History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • The researcher considers it inappropriate to enter this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

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.

Read the detailed description

Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time； Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Being tested
HAIC+TAE, Tislelizumab, Surufatinib
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAIC+TAEDrug

    Procedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ，continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days.

  • TislelizumabDrug

    Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks

  • SurufatinibDrug

    Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.

Study groups in NCT06239532
Study groupRoleWhat they receive
TAE+HAIC+Tislelizumab+SurufatinibExperimentalPatients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
Receives: Drug: HAIC+TAE; Drug: Tislelizumab; Drug: Surufatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    the sum of complete response rate and partial response rate

    Measured: 24 months

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    Time from randomization to disease progression

    Measured: 24 months

  2. Conversion to surgical resection rate

    Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated

    Measured: 3 months

  3. Overall survival (OS)

    Time from randomization to death for any cause

    Measured: 24 months

  4. 1-year overall survival rate

    one year overall survival rate

    Measured: 12 months

  5. Disease Control rate (DCR)

    the sum of complete response rate, partial response rate and stable disease rate

    Measured: 24 months

  6. Incidence rate of adverse events

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start27 Sep 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06239532
Sponsor's protocol ID
REACH-01
Status last verified
Nov 2024
First submitted
28 Dec 2023
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.

    PubMed 40812353

  • Li KS, Liu Y, Zhang TZ, Xu YF, Zhang ZL. Protocol of REACH-01: a single-arm, open label, prospective study of HAIC sequential TAE combined with tislelizumab and surufatinib in unresectable intrahepatic cholangiocarcinoma. Front Pharmacol. 2024 Nov 18;15:1435639. doi: 10.3389/fphar.2024.1435639. eCollection 2024.

    PubMed 39624833

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HAIC+TAE, Tislelizumab and Surufatinib in people with Intrahepatic Cholangiocarcinoma, run by Qilu Hospital of Shandong 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

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: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06239532, which also lists 2 linked publications.

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 21 Nov 2024.

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