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

Last updated: November 18, 2024
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Digestive System Neoplasms

Biliary Tract Cancer

Abdominal Cancer

Treatment

Tislelizumab

Surufatinib

HAIC+TAE

Clinical Study ID

NCT06239532
REACH-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent for the trial.

  2. Aged ≥18 years.

  3. Histologically confirmed intrahepatic cholangiocarcinoma.

  4. No other previous systematic treatment for BTC.

  5. At least one measurable lesion (RECIST 1.1).

  6. Eastern Cooperative Oncology Group performance status 0 or 1.

  7. Life expectancy of 3 months or greater.

  8. Child-Pugh classification score ≤7.

Exclusion

Exclusion Criteria:

  1. Recurrent patients.

  2. Eastern Cooperative Oncology Group performance status ≥ 2.

  3. Life expectancy of less than 3 months.

  4. Child-Pugh classification score > 8.

  5. History of hepatic encephalopathy or liver transplantation.

  6. Known hypersensitivity to any of the study drugs, study drug classes, or excipientsin the formulation.

  7. Symptomatic pleural effusion, ascites, and pericardial effusion that requiredrainage.

  8. Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateralbranch or upper mesenteric vein. Inferior vena cava tumor thrombus.

  9. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,anti-CTLA4, etc.).

  10. History of (non-infectious) pneumonitis that required steroids, evidence ofinterstitial lung disease or active, non-infectious pneumonitis.

  11. The researcher considers it inappropriate to enter this study.

Study Design

Total Participants: 28
Treatment Group(s): 3
Primary Treatment: Tislelizumab
Phase: 2
Study Start date:
September 27, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

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