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Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models

ConditionsHCCPrecision Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaoping

About this trial

Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75.

No previous local or systemic treatment for hepatocellular carcinoma.

Child-Pugh liver function score ≤ 7.

ECOG PS 0-1.

Disqualifiers

Pregnant and lactating women.

Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).

A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.

Active infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • HAIC + Tislelizumab +lenvatinib

    Drug

    All patients were treated with HAIC combined with tislelizumab and lenvatinib. 1. HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days. 2. Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight. 3. First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combined therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Objective response rate(ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the mRESIST criteria.

Time frame
From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.

Secondary outcomes

1

Overall survival

OS is defined as the time from enrollment to death from any cause.

Time frame
From date of enrollment until the date of death from any cause, assessed up to 60 months.
2

Safety Assessment

Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication.The incidence and severity of adverse events and serious adverse events as assessed by CTCAE v5.0.

Time frame
Baseline up to study termination, assessed up to 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chen Xiaoping

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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