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Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion

NCT07738055 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-30

No results posted yet for this study

Summary

This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1/3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1/3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.

Conditions

  • Potentially Resectable Hepatocellular Carcinoma

Interventions

DRUG

Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks

Suvemcitug is administered via intravenous infusion at a fixed dose of 2 mg/kg on Day 1 of every 21-day cycle (Q3W). Envafolimab is given by subcutaneous injection at a fixed dose of 400 mg on Day 1 of every 21-day cycle (Q3W). Concurrent Hepatic Artery Infusion Chemotherapy (HAIC) adopts standard FOLFOX regimen: Oxaliplatin 85 mg/m² administered via hepatic artery catheter, followed by continuous infusion of 5-Fluorouracil at a dose range of 2400-3200 mg/m², repeated every 3 weeks. This triple combination neoadjuvant conversion therapy will be administered for a maximum of 3 cycles to eligible patients with potentially resectable hepatocellular carcinoma (HCC) in this single-arm, single-center exploratory clinical trial. Tumor imaging assessments will be conducted in accordance with RECIST Version 1.1 at two specified time points: baseline before treatment initiation, and within ±3 days after completion of the 3rd treatment cycle. After finishing 3 cycles of combination therapy, a mul

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-01-31
Completion
2029-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738055 on ClinicalTrials.gov