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A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

ConditionsHCC - Hepatocellular CarcinomaIparomlimab and Tuvonralimab InjectionNeoadjuvant Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participate in this study and sign the informed consent form.

Aged 18 to 75 years, male or female.

ECOG Performance Status (PS) score of 0 to 1.

Child-Pugh liver function classification: Grade A.

Disqualifiers

Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.

Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.

Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.

The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab

    Drug

    Patients in the neoadjuvant Iparomlimab and Tuvonralimab group received 2 cycles of 7.5 mg/kg iv d1 q3w, followed by elective surgery 2-3 weeks thereafter.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year disease-free survival rate

To measure and report the proportion of patients alive and free of disease recurrence, metastasis, or death within 1 year after radical resection.

Time frame
2 years

Secondary outcomes

1

Incidence of microvascular invasion (MVI)

To evaluate and report the presence or absence of microvascular invasion in postoperative pathological specimens, and to report the overall incidence rate.

Time frame
2 years
2

Pathological complete response (pCR) rate

To measure and report the proportion of patients achieving no residual viable tumor cells in resected hepatic specimens after neoadjuvant therapy.

Time frame
2 years
3

Objective response rate (ORR)

To calculate and report the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST criteria.

Time frame
2 years
4

2-year disease-free survival (DFS) rate

To measure and report the proportion of patients alive and free of disease recurrence, metastasis, or death within 2 years after radical resection.

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: