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New triple therapy aims to stop liver cancer from coming back

NCT ID NCT07618546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a combination of chemotherapy directly into the liver (HAIC) plus two drugs (camrelizumab and apatinib) before and after surgery can prevent liver cancer from returning in high-risk patients. About 208 people with resectable liver cancer and high-risk features will be randomly assigned to either the triple therapy plus surgery or surgery alone. The main goal is to see if the combo improves how long patients live without their cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
camrelizumab, apatinib mesylate, and FOLFOX-HAIC (oxaliplatin, leucovorin, 5-fluorouracil)
What this could lead to
If successful, this combination could lower the chance of liver cancer returning after surgery, improving long-term survival for high-risk patients.
What could go wrong
This is an early-stage trial with only 208 participants, so results may not apply to everyone. The drugs can cause serious side effects like immune reactions or liver damage.

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

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

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1: 1. Age 18-80, both male and female are acceptable; 2: 2. Hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or imaging, with CNLC staging of Ia-IIIa, excluding patients with stage IIIa HCC combined with main portal vein tumor thrombus; 3: 3. Meets the indications for radical surgical resection; 4: 4. There are clearly defined high-risk recurrence factors (tumor diameter \>5 cm, microvascular invasion, satellite lesions, incomplete tumor capsule, alpha-fetoprotein \>400 μg/L, etc.; 5: 5. ECOG: 0-1; 6: 6. The functions of major organs have been assessed and meet the requirements for the study treatment; 7: 7. Has not previously received systematic treatment. 8: 8. Expected survival time ≥ 12 weeks; 9: 9. Baseline blood cell count tests and blood biochemistry must meet the following criteria: white blood cell count ≥ 3.0 × 10\^9/L; hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 75 × 10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L; 10: 10. Women of childbearing age must agree to use contraception (such as intrauterine devices, contraceptive pills, or condoms) during the study period and for 6 months after the end of the study; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment in the study and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the study ends. 11: 11. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up. Exclusion Criteria: * 1: 1. Merge distant metastases; 2: 2. Those allergic to camrelizumab and apatinib mesylate; 3: 3. Previously received systemic or local treatment for liver cancer; 4: 4. Pleural effusion, pericardial effusion, or ascites accompanied by clinical symptoms and judged by the investigator to require frequent drainage; 5: 5. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 6: 6. Active or uncontrolled serious infections (≥CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, and unexplained fever \>38.5°C before the first dose; 7: 7. Those with a history of abuse of psychotropic drugs who are unable to quit, or who have mental disorders; 8: 8.5 Subjects who have had or currently have other malignant tumors requiring active treatment (excluding those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate \>90%, carcinoma in situ of the cervix, or carcinoma in situ of the breast); 9: 9. Presence of uncorrectable coagulation disorders; 10: 10. Cardiovascular diseases with significant clinical relevance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class ≥ 2; ventricular arrhythmias requiring medication (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females); left ventricular ejection fraction (LVEF) \<50%; 11: 11. Severe liver disease (such as cirrhosis), kidney disease, respiratory system diseases, uncontrolled diabetes, or other types of systemic diseases. 12: 12. Imaging shows that the tumor has invaded major blood vessels, or the researcher judges that during subsequent studies, the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding; 13: 13. Patients with active autoimmune diseases or immunodeficiency, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., shall not be included. Exceptions are as follows: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study. 14: 14. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \>10mg/day of prednisone or other equivalent steroids, and still using within 2 weeks prior to enrollment); 15: 15. Experienced arterial/venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism; 16: 16. The investigator assesses digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or incompletely resected gastrointestinal tumors with active bleeding, or other conditions deemed by the investigator that may cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction). 17: 17. Hypertension not adequately controlled by medication is defined as: systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg; 18: 18. Underwent surgery (excluding biopsy) within 28 days before being enrolled in this study, or the surgical incision has not completely healed; 19: 19. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent form; 20: 20. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 21: 21. According to the researcher's judgment, the patient is considered not suitable for enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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