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HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma

NCT06475287 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-26

No results posted yet for this study

Summary

Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.

Conditions

Interventions

DRUG

HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450

The combination therapy of HAIC with TQB2450 and Anlotinib was administered to enrolled patients in no particular order. Patients received routine hepatic artery catheterization via femoral artery puncture, followed by routine hepatic artery catheterization and infusion chemotherapy with 5% sodium bicarbonate 150ml + liposomal mitoxantrone (10mg) for 2-4 hours + Raltitrexed (2mg/m2) for 2-4 hours, every three weeks for at least two cycles. Systemic treatment was given every 21 days, with a fixed dose of 1200mg of TQB2450 injection on the first day of each systemic treatment cycle (1-7 days after HAIC treatment), administered intravenously over 60 minutes initially, followed by 30 minutes if tolerated. Anlotinib was administered orally once daily at a dose of 10mg, with a two-week break every three weeks. Treatment continued until unacceptable toxicity or loss of clinical benefit (as assessed by the investigator based on imaging, biochemical indicators, and patient clinical status).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475287 on ClinicalTrials.gov