TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

Last updated: June 27, 2024
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abdominal Cancer

Biliary Tract Cancer

Digestive System Neoplasms

Treatment

TACE with ICI

Clinical Study ID

NCT06487663
TCHIO-001
  • Ages 18-75
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of HCC by histology/ cytology or clinical criteria

  • Sign informed consent

  • When screening for age, the age should be ≥ 18 years old

  • Eligible for TACE treatment

  • ECOG physical condition score is 0 or 1

  • No prior systemic therapy for HCC, especially immunotherapy

  • According to the following mRECIST criteria, at least one measurable intrahepaticlesion is suitable for repeated evaluation

Exclusion

Exclusion Criteria:

  • Have any history of kidney disease or nephrotic syndrome

  • Evidence of extrahepatic spread (EHS)

  • Cardiovascular diseases with clinical significance (such as activity), includingunstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drugtreatment control

  • Any condition representing a contraindication to TACE as determined by theinvestigators

  • Known genetic factors for bleeding or thrombosis; Any previous or current evidenceindicating a tendency for bleeding

  • Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4treatment)

  • Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepaticartery chemoembolization), TAE (hepatic artery embolization), or TARE (hepaticartery radiation embolization)

  • Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: TACE with ICI
Phase:
Study Start date:
October 27, 2020
Estimated Completion Date:
October 27, 2026

Study Description

The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.

Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin,
    China

    Active - Recruiting

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