New combo aims to stop liver cancer from coming back after surgery
NCT ID NCT06467799
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether giving chemotherapy directly into the liver artery plus an immunotherapy drug (tislelizumab) before surgery, followed by more immunotherapy after surgery, can prevent liver cancer from returning in high-risk patients. The study enrolls 39 adults with hepatocellular carcinoma beyond Milan criteria. The main goal is to see how many patients remain cancer-free one year after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab (an immunotherapy drug) and FOLFOX chemotherapy given directly into the liver artery
- What this could lead to
- If successful, this approach could reduce the chance of liver cancer returning after surgery, potentially improving long-term survival for high-risk patients.
- What could go wrong
- This is a small, early-phase trial with only 39 participants and no comparison group, so results may not apply broadly. The combination therapy also carries risks of side effects from both chemotherapy and immunotherapy.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2024
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL)); 2. Tumor staging: beyond Milan criteria (single tumor \>5 cm, or 2-3 tumors with the largest diameter \>3 cm), resectable CNLC stage Ib/IIa hepatocellular carcinoma; 3. No tumor thrombus, distant metastasis, or lymph node metastasis; 4. Normal liver volume ≥ 700 cc, estimated residual liver volume \>40% after resection; 5. Patient KPS ≥ 90; 6. Liver function Child-Pugh class A; 7. Estimated survival of more than 6 months; 8. Function of important organs meets the following requirements: white blood cells ≥ 4.0×10\^9/l, neutrophils ≥ 1.5×10\^9/l, platelets ≥ 80.0×10\^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5 × ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min; no severe organic diseases; 9. The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication and postoperative follow-up requirements as designed in this study. Exclusion Criteria: 1. Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment; 2. Contraindications to surgical resection and immunotherapy; 3. History of other malignant tumors; 4. Combined with immunological diseases or other conditions requiring long-term steroid treatment; 5. Known or suspected allergy to the study drug or any drugs administered in connection with this trial; 6. History of organ transplantation; 7. Pregnant or breastfeeding women; 8. Other factors that may affect patient enrollment and assessment outcomes; 9. Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Beyond milan criteria are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial