New drug combo shows promise in shrinking liver tumors before surgery
NCT ID NCT05807776
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tested whether giving the immunotherapy drug tislelizumab, alone or combined with the targeted therapy lenvatinib, before surgery could help shrink liver tumors in 36 patients with resectable hepatocellular carcinoma. The main goal was to see if at least half of the tumor would die (tumor necrosis rate ≥50%). The study also looked at survival, side effects, and whether the drugs delayed 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 and lenvatinib
- What this could lead to
- If successful, this approach could shrink liver tumors before surgery, potentially improving outcomes and reducing recurrence.
- What could go wrong
- This is a small, early-phase trial with only 36 participants. Results may not apply to all patients, and side effects from the drugs could delay 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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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36 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jul 2025
- 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
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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. Patients must have a known diagnosis of HCC as defined in the protocol 2. Patients must be evaluated by the Department of Hepatobiliary Oncology, Tianjin Medical University Cancer Hospital to determine whether they can complete surgical treatment. Patients can be resectable in both oncology and surgery. 3. At least ≥1 measurable lesion (RECIST 1.1) 4. Age 18-75, male or female 5. ECOG PS 0-1 6. Child-pugh A 7. The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) Blood routine: Neutrophils ≥1.5×109//L Platelet count ≥100×109/L Hemoglobin ≥90g/L Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times 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) AST or ALT levels ≤ 3 times the upper limit of normal value (ULN) 8. Normal coagulation function, International standardized ratio INR≤1.5×ULN or Prothrombin time PT≤1.5ULN 9. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range may be enrolled if total T3 (or FT3) and FT4 are within the normal range. 10. Myocardial enzyme profiles were within the normal range (simple laboratory abnormalities that were not clinically significant were also allowed to be included) 11. Patients who have progressed to PD or increased SD after 2 cycles of tislelizumab monotherapy must be willing to continue 2 cycles of tislelizumab and Lenvatinib combination therapy and be evaluated. Exclusion Criteria: 1. Have received any systemic anticancer therapy or radiotherapy for their current tumor or other primary tumor in the 6 months prior to study entry. 2. Tumor load or tumor growth rate was considered by the investigator to be insufficient to delay surgery. 3. Had major surgery within 14 days prior to neoadjuvant therapy. 4. Uncontrolled co-morbidities defined in the protocol and identified by the investigator. 5. Receiving systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to administration of the first dose of study therapy. 6. Have had an active autoimmune disease requiring systemic treatment within the past 1 year. 7. Have other malignancies that are known, developing and/or require aggressive treatment. 8. Informed consent to encephalitis, meningitis, or uncontrolled seizures in the previous year. 9. A history of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, systemic pneumonia) or active non-infectious pneumonia requires immunosuppressive doses of glucocorticoids to assist in treatment. 10. Bleeding from esophageal or fundus varices caused by portal hypertension in the past 6 months; Severe (G3) varicose veins were known on endoscopy within 3 months prior to initial administration; Patients with evidence of portal hypertension (including imaging findings of a large spleen diameter of more than 10cm and platelets of less than 100) were at high risk of bleeding as assessed by the investigators. 11. History of arteriovenous thromboembolism events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, except in patients with stable thrombus after conventional anticoagulant therapy. 12. Severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy. 13. Prophylactic use of low-dose, low-molecular heparin (e.g., enoxaparin 40 mg/ day) is permitted, except for vitamin K antagonists (e.g., warfarin). 14. Long-term use of drugs that inhibit platelet function such as aspirin, dipyridamole or clopidogrel is required. 15. Uncontrolled hypertension, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 16. Symptomatic congestive heart failure (New York Cardiological Association Grade II-IV), symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome or adjusted QTc \> 500ms at screening (calculated using the Fridericia method). 17. A previous history of gastrointestinal perforation and/or fistula within the past 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Liver cancer patients get Pre-Surgery combo: radiation plus immunotherapy shows promise