Can a Triple-Drug cocktail turn inoperable liver cancer into a surgical target?
NCT ID NCT07738055
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial is testing whether a combination of two newer drugs—envafolimab and suvemcitug—plus chemotherapy delivered directly to the liver can shrink advanced liver tumors enough to allow surgery. The study enrolls adults aged 18–75 with liver cancer that is currently too advanced for surgery. Participants receive three cycles of the combination, then doctors check if the tumors have shrunk enough for safe removal. The goal is to see if this approach can convert more cases to operable ones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of envafolimab (an immunotherapy), suvemcitug (an anti-angiogenic drug), and HAIC (chemotherapy infused into the liver artery)
- What this could lead to
- If successful, this approach could help more patients with advanced liver cancer become eligible for surgery, potentially improving long-term outcomes.
- What could go wrong
- This is a small, early exploratory study with only 35 participants. The combination may cause serious side effects, and it is not yet known if it will effectively shrink tumors enough for surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Sign a written informed consent form before enrollment; 2. Age 18-75 years old; 3. Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment; 4. Patients with stage IV or III unresectable liver cancer; 5. Have measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions with CT scan diameter ≥ 10 mm, lymph node lesions with CT scan diameter ≥ 15 mm); 6. Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment; 7. Child-Pugh score ≤ 7 points; 8. Have sufficient organ function; 1) Blood routine: White blood cell (WBC) ≥ 3.5 × 10\^9/L, absolute neutrophil count (ANC) 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (HGB) ≥ 90 g/L; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (using the standard Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR) ≤ 1.5 / PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation treatment, as long as PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable. 10\. Estimated survival period ≥ 3 months; 11. Pregnant women should agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 6 months after the study; the serum HCG test should be negative within 7 days before enrollment, and must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the study. Exclusion Criteria: 1. Those who refuse to sign the informed consent form or refuse to undergo follow-up; 2. Subjects who have previously or concurrently suffered from other malignant tumors; 3. Patients who have received systemic anti-tumor treatment in the past; 4. Those who are currently candidates for liver transplantation or have undergone liver transplantation; 5. Those with a risk of bleeding, or coagulation dysfunction, or are undergoing thrombolytic therapy; or have experienced esophageal or gastric variceal bleeding within the past 6 months; 6. Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs; 7. Subjects with any active autoimmune diseases or a history of autoimmune diseases (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs that cannot maintain thyroid function within the normal range, or previous thyroid surgery, and long-term thyroid hormone replacement therapy is required after the surgery; subjects with vitiligo or who had completely resolved asthma in childhood and do not require any intervention in adulthood can be included; subjects with asthma who require bronchodilators for medical intervention cannot be included); 8. Subjects who are currently using immunosuppressants, or systemic, or absorbable local hormone treatments to achieve immunosuppression purposes (dose \> 10mg/day prednisone or other drugs with equivalent efficacy), and are still using them within 2 weeks before enrollment; 9. Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment; 10. Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 11. Subjects with congenital or acquired immune deficiencies, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, for hepatitis B: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; for hepatitis C: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide antiviral treatment, below the above standards can be included); chronic hepatitis B virus carriers, HBV DNA \< 104 IU/ml, can be enrolled during the trial period if they must receive antiviral treatment simultaneously; 12. Less than 4 weeks before the study medication, or may have received live vaccines during the study period; 13. Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse; 14. The investigator considers it necessary to exclude from this study, for example, if the subject is judged by the investigator to have other factors that may cause the study to be prematurely terminated, such as, other serious diseases (including mental disorders) that require combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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