A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment … (NCT07515469) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
30 participantsStarted 2026-05-30
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Histopathologically confirmed primary hepatocellular carcinoma (HCC), and the lesions meet the surgical resection indications specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).
* Preoperatively, evaluated by the investigator, with high recurrence risk factors, meeting at least one of the following: Stage IB: Single tumor with maximum diameter \> 5 cm; 2-3 tumors with maximum tumor diameter ≤ 3 cm;Stage IIA: 2-3 tumors with maximum tumor diameter \> 3 cm.
* According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion with a long diameter ≥ 10 mm on CT/MRI scan or lymph node lesion with a short diameter ≥ 15 mm on CT/MRI scan, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy).
* Expected survival time ≥ 6 months
* possess normal and sound organ function
* Females of childbearing age must agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the medication period and within 6 months after the end of medication; serum or urine pregnancy test is negative within 7 days before study enrollment, and must be a non-lactating patient; males must agree to use cont…
What they're measuring
1
1-year disease-free survival rate
Timeframe: 2 years
Trial details
NCT IDNCT07515469
SponsorTianjin Medical University Cancer Institute and Hospital