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NCT Number: NCT06239532

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

HAIC+TAE

Drug

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.

Tislelizumab

Drug

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

Surufatinib

Drug

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 24 months

    the sum of complete response rate and partial response rate

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 24 months

    Time from randomization to disease progression

  2. Conversion to surgical resection rate

    Time frame: 3 months

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

  3. Overall survival (OS)

    Time frame: 24 months

    Time from randomization to death for any cause

  4. 1-year overall survival rate

    Time frame: 12 months

    one year overall survival rate

  5. Disease Control rate (DCR)

    Time frame: 24 months

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

  6. Incidence rate of adverse events

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • BeiGene

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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