Potentially Resectable Hepatocellular CarcinomaHCCNCT07738055
Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion
A study testing Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks in people with Potentially Resectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Potentially Resectable Hepatocellular Carcinoma
- What is being tested?
- Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form before enrollment;
- Age 18-75 years old;
- Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;
- Patients with stage IV or III unresectable liver cancer;
- 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);
- Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment;
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- Child-Pugh score ≤ 7 points;
- 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.
Who cannot join
- Those who refuse to sign the informed consent form or refuse to undergo follow-up;
- Subjects who have previously or concurrently suffered from other malignant tumors;
- Patients who have received systemic anti-tumor treatment in the past;
- Those who are currently candidates for liver transplantation or have undergone liver transplantation;
- 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;
- Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs;
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- 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);
- 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;
- Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment;
- 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;
- 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;
- Less than 4 weeks before the study medication, or may have received live vaccines during the study period;
- Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma
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.
- Being tested
- Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks
- Keywords
- Potentially resectable hepatocellular carcinoma, Envafolimab, Suvemcitug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeksDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Receive three cycles of conversion therapy with Envafolimab combined with Suvemcitug and HAIC. | Experimental | Dosage regimen:
Envafolimab: 400mg, subcutaneous injection (every 3 weeks) Suvemcitug: 2mg/kg, intravenous injection (every 3 weeks) HAIC: Based on the FOLFOX regimen, HAIC uses oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m² for continuous infusion, repeated every 3 weeks Receives: Drug: Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conversion rate
Measured: The conversion rate for the first to third cycles of medication (each cycle lasting 21 days)
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1. [Time Frame: During the first to third cycles of medication (each cycle lasting 21 days).]
Major Pathological Response (MPR)
Measured: The assessment will be conducted during the first to third cycles of medication (each cycle lasting 21 days) after the surgery.
Progression-Free Survival (PFS)
Measured: Time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: From start of treatment to disease progression or death（Each cycle lasts for 21 days.）]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738055
- Sponsor's protocol ID
- EC-2026-0132
- Acronym
- HCC
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07738055
- Acronym / sponsor ID
- HCC / EC-2026-0132
- Keywords
- Potentially resectable hepatocellular carcinoma, Envafolimab, Suvemcitug
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receive three cycles of conversion therapy with Envafolimab combined with Suvemcitug and HAIC. | Experimental | Drug: Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeksDosage regimen: Envafolimab: 400mg, subcutaneous injection (every 3 weeks) Suvemcitug: 2mg/kg, intravenous injection (every 3 weeks) HAIC: Based on the FOLFOX regimen, HAIC uses oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m² for continuous infusion, repeated every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign a written informed consent form before enrollment;
- Age 18-75 years old;
- Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;
- Patients with stage IV or III unresectable liver cancer;
- 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);
Key exclusion criteria (14 listed)
- Those who refuse to sign the informed consent form or refuse to undergo follow-up;
- Subjects who have previously or concurrently suffered from other malignant tumors;
- Patients who have received systemic anti-tumor treatment in the past;
- Those who are currently candidates for liver transplantation or have undergone liver transplantation;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeksSuvemcitug 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 | Drug | Receive three cycles of conversion therapy with Envafolimab combined with Suvemcitug and HAIC. |
Primary outcome
Surgical conversion rate
Time frame: The conversion rate for the first to third cycles of medication (each cycle lasting 21 days)
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1. [Time Frame: During the first to third cycles of medication (each cycle lasting 21 days).]
Major Pathological Response (MPR)
Time frame: The assessment will be conducted during the first to third cycles of medication (each cycle lasting 21 days) after the surgery.
Progression-Free Survival (PFS)
Time frame: Time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: From start of treatment to disease progression or death（Each cycle lasts for 21 days.）]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Envafolimab: 400mg, subcutaneous injection Suvemcitug: 2mg/kg, intravenous injection HAIC: Oxaliplatin 85mg/m² + 5-FU 2400-3200mg/m², continuous infusion, every 3 weeks in people with Potentially Resectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huikai Li,MD Huikai Li,MD (86+18622228639, vianvianvip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical conversion rate (time frame: The conversion rate for the first to third cycles of medication (each cycle lasting 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.