Health TrialsbyHealthPanel

Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model

ConditionHCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaoping

About this trial

Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, the early recurrence rate of high-risk HCC is very high, which seriously affects the overall therapeutic effect.

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

Parallel

Treatments tested in this trial

  • Hepatic arterial infusion chemotherapy

    Procedure/Surgery

    Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days)

  • Lenvatinib

    Drug

    Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight).

  • Tislelizumab

    Drug

    Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)

  • Liver resection

    Procedure/Surgery

    Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection.

  • Tislelizumab

    Drug

    Given the high risk of postoperative recurrence, patients in both groups received adjuvant Tis therapy (every 21 days for 8 cycles) starting about one month after surgery.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant therapy groupExperimental treatment 4 interventions
Group B: Direct liver resection groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Median event-free survival (EFS)

EFS is defined as the time from randomization to disease recurrence and/or disease progression or death from any cause.

Time frame
From date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary outcomes

1

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 12 months
2

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause

Time frame
From date of randomization until the date of death from any cause, assessed up to 60 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
Apply now