Can Pre-Surgery drug cocktail stop liver cancer from coming back?
NCT ID NCT05621499
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial is testing whether giving a combination of drugs before surgery can reduce the risk of liver cancer returning in patients with a single, early-stage tumor that has a high chance of recurrence. Participants will receive either chemotherapy directly into the liver or a targeted therapy pill, both combined with an immunotherapy drug. The goal is to see if these pre-surgery treatments improve disease-free survival after the tumor is removed.
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 either chemotherapy infused into the liver (HAIC) or the targeted drug lenvatinib, plus the immunotherapy drug sintilimab
- What this could lead to
- If successful, this approach could lower the chance of liver cancer returning after surgery for patients at high risk.
- What could go wrong
- This is an early exploratory trial with only 60 participants, so results may not apply broadly. Combining treatments also raises the risk of side effects.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
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: * Volunteer to join the study and signed the informed consent form * Aged 18-75, male or female * ECOG PS score 0-1 * Child Pugh liver function Grade A * Histopathology confirmed primary hepatocellular carcinoma (HCC) and the lesion met the indications for surgical resection in the Diagnostic and Therapeutic Norms for Primary Liver Cancer (2022) * According to the investigator's assessment, there are the following high recurrence risk factors, Stage Ⅰ b: solitary tumor, with the largest diameter \> 5cm * At least one measurable lesion according to RECIST 1.1 (measurable lesion CT/MRI scan length diameter ≥ 10mm or lymph node lesion CT/MRI scan short diameter ≥ 15mm, and measurable lesion has not received radiotherapy, cryotherapy and other local treatments) * Expected life ≥ 6 months * Functions of important organs shall meet the following requirements (excluding the use of any blood component and cell growth factor within 14 days) Neutrophils ≥ 1500/mm3Platelet count ≥ 60,000/mm3Hemoglobin ≥ 5.6 mmol/L (9 g/dL); Serum creatinine (SCR) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN); Urine protein\<2+; If urinary protein ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g * Normal coagulation function, no active bleeding and thrombosis disease 1. International normalized ratio INR ≤ 1.5 × ULN; 2. Partial thromboplastin time APTT ≤ 1.5 × ULN; 3. Prothrombin time PT ≤ 1.5ULN; * Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the medication period and within 6 months after the end of medication; If the serum or urine pregnancy test was negative within 7 days before the study included, and the patient must be a non lactating patient, the male should agree to use contraception during the study period and within 6 months after the end of the study period * The subjects had good compliance and cooperated with follow-up. Exclusion Criteria: * Previously received radiotherapy, chemotherapy, concurrent radiotherapy and chemotherapy or other targeted therapies * Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Have other active malignant tumors except HCC within 5 years or at the same time * Patients with hypertension who cannot be well controlled after antihypertensive drug treatment (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Previous hypertension crisis or hypertensive encephalopathy * Patients had other malignant tumors in the past or at the same time (except cured skin basal cell carcinoma and cervical carcinoma in situ); * Patients who had been treated with Sintilimab or other PD-1/PD-L1 inhibitors in the past could not be included; Known hypersensitivity to macromolecular protein preparations or any excipients of Sintilimab or lenvatinib * Patients have any active autoimmune diseases or have a history of autoimmune diseases (Including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or asthma in childhood has completely alleviated, without any intervention after adulthood can be included; Patients with asthma requiring medical intervention of bronchodilators cannot be included) * Patients who are using immunosuppressive agents, or systemic or absorbable local hormone to achieve immunosuppressive purpose (Dose\>10mg/day prednisone or other equivalent therapeutic hormones) and continue to use them within 2 weeks before enrollment * Ascites or pleural effusion with clinical symptoms and requiring therapeutic puncture or drainage * There are clinical symptoms or diseases of the heart that are not well controlled, such as: 1. Heart failure above NYHA level 2 2. Unstable angina pectoris 3. Myocardial infarction occurred within 1 year 4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention * Patients having gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from tumors that have not been removed, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator at present (within 3 months) * Serious bleeding (\>30 ml bleeding within 3 months), hemoptysis (\>5 ml fresh blood within 4 weeks) or thromboembolism (including stroke and/or transient ischemic attack) occurred in the past or present * Patients with active infection or fever of unknown origin\>38.5℃during the screening period and before the first administration (according to the judgment of the investigator, subjects with fever due to tumor can be included) * Patients with past or current objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function * Patients with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria: HBV DNA ≥ 10e4/ml; HCV RNA ≥ 10e3/ml); Chronic hepatitis B virus carriers with HBV DNA\<2000 IU/ml (\<10e4 copies/ml) receive antiviral treatment at the same time during the trial can be included * Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period * Known history of abuse of psychotropic substances, alcohol abuse or drug abuse * Conditions should be excluded according to the judgment of the investigator, for example, according to the judgment of the investigator, the patient has other factors that may lead to the forced termination of the study, such as other serious diseases requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which 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.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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