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Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC

ConditionHCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLei ZHAO

About this trial

This study is a single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma.

After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group:

* Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks. Lenvatinib 8 mg was orally administered once daily, combined with the HAIC-FOLFOX regimen. After two cycles, the patients' conditions were evaluated for surgery. * Subjects in the control group underwent surgery directly.

Both groups of subjects received sintilimab monotherapy as adjuvant treatment for half a year (a total of 8 cycles) after surgery. The treatment was terminated if there was disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or other reasons stipulated in the protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign a written informed consent before the implementation of any trial-related procedures.

Male or female, aged ≥18 years and ≤70 years.

ECOG PS score of 0-2.

Diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer in China (2019 Edition).

Disqualifiers

Previously histologically/cytologically confirmed liver cancer with components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.

History of hepatic encephalopathy or liver transplantation.

Clinical symptoms requiring drainage of pleural effusion, ascites, or pericardial effusion.

Acute or chronic active hepatitis B or C infection, with HBV DNA > 2000 IU/ml or 104 copies/ml; HCV RNA > 103 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibody.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HAIC

    Procedure/Surgery

    FOLFOX-hepatic artery infusion

  • Sintilimab

    Drug

    200mg, ivgtt, D1, Q3W

  • Lenvatinib

    Drug

    8 mg，qd，D1-D21,Q3W

  • surgery

    Procedure/Surgery

    surgery

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Experimental：Sintilimab+ Lenvatinib+HAIC+surgeryExperimental treatment 4 interventions
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

One-year disease-free survival rate

The 1-year disease-free survival rate (1-year DFS rate) of the experimental group and the control group

Time frame
From enrollment to the end of treatment at one year

Secondary outcomes

1

disease-free survival（DFS）

The time from enrollment to the first radiological disease recurrence or death (whichever occurred first)

Time frame
From enrollment to the end of treatment，assessed up to 3 years
2

Overall survival (OS)

as the time from enrollment to the death of the subject for any reason

Time frame
Up to three years
3

Pathologic complete response (pCR)

The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells

Time frame
Up to one year

Other outcomes

Sponsors and contacts

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

Lei ZHAO

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Source ClinicalTrials.gov
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