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Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence

ConditionResectable Hepatocellular Carcinoma With High Risk of Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hepatocellular carcinoma is proven on biopsy or confirmed by the presence of radiological hallmarks, according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines.

Aged 18 to 75 years.

BCLC A/B, or BCLC C without extrahepatic metastasis.

Suitable for radical surgery after evaluation by the hepatobiliary tumor MDT expert group.

Disqualifiers

Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.

History of hepatic encephalopathy or liver transplantation.

Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Subjects with only radiologically detected minimal pleural effusion, ascites, or pericardial effusion without symptoms can be enrolled.

Acute or chronic active hepatitis B or C infection, with hepatitis B virus (HBV) DNA >2000IU/ml or 10^4 copies/ml; hepatitis C virus (HCV) RNA >10^3 copies/ml; co-positive for hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Subjects who meet the above criteria after antiviral treatment with nucleoside analogs can be enrolled.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab (QL1706)

    Drug

    Neoadjuvant phase: A single cycle of Iparomlimab and Tuvonralimab (7.5 mg/kg) will be administered within 1 week prior to surgery. Adjuvant phase: Six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be initiated starting at 2 weeks postoperatively.

  • Partial hepatectomy

    Procedure/Surgery

    Will be performed at an appropriate interval following neoadjuvant therapy initiation.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Experimental: Iparomlimab and TuvonralimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recurrence-Free Survival (RFS)

The duration will be calculated from the date of achieving complete response (CR) after surgery to the first documented occurrence of intrahepatic or extrahepatic HCC recurrence, or death from any cause, whichever comes first.

Time frame
From the date of achieving complete response (CR) after surgery until the date of first documented recurrence or death from any cause, assessed up to 24 months post-surgery.

Secondary outcomes

1

Overall Survival (OS)

Overall survival (OS): measured from date of first treatment to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last visit.

Time frame
from the date of first treatment to the date of death from any cause, assessed up to 5 years
2

Major Pathological Response (MPR)

Defined as the presence of ≤50% residual viable tumor cells in the resected specimen confirmed by postoperative pathological examination.

Time frame
Intraoperative frozen section assessment and final postoperative pathology (assessed within 4 weeks after surgery).
3

Investigator-Assessed Recurrence-Free Survival (RFS)

Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence, or death from any cause (whichever occurs first), as determined by the investigator.

Time frame
From treatment initiation until the date of first documented HCC recurrence or death from any cause, whichever occurs first, assessed up to 24 months.
4

Time to Recurrence (TTR)

Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence event.

Time frame
From treatment initiation until the date of first documented HCC recurrence, assessed up to 24 months.

Other outcomes

Sponsors and contacts

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

Tongji Hospital

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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