Liver cancer patients get new hope: study tests two drug cocktails after first treatment fails
NCT ID NCT07537985
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at 200 people with advanced liver cancer whose first treatment (bevacizumab plus sintilimab) stopped working. Researchers compared two second-line options: a PD-1 inhibitor combined with either lenvatinib or regorafenib. The goal was to see which combo works better and is safer. The study is complete, but results are not yet published.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 inhibitors (such as sintilimab, camrelizumab, pembrolizumab, nivolumab) combined with lenvatinib or regorafenib
- What this could lead to
- If successful, this could help doctors choose the best second-line treatment for advanced liver cancer patients who have already tried one therapy.
- What could go wrong
- This is a retrospective study, not a controlled trial, so results may be less reliable. The drugs can cause serious side effects like liver damage or bleeding.
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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200 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Dec 2025
- 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: 1. Diagnosed with hepatocellular carcinoma (HCC) based on histological or clinical diagnostic criteria; 2. Classified as unresectable HCC following multidisciplinary assessment; 3. Presence of at least one tumor lesion measurable according to EASL criteria; 4. Patients aged ≥18 years and ≤75 years receiving first-line treatment; 5. Child-Pugh liver function class A/B, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0-2; 6. Disease progression confirmed by CT/MRI and evaluated according to modified RECIST (mRECIST)/RECIST v1.1 criteria after ≥2 cycles of first-line therapy with bevacizumab (15 mg/kg intravenous infusion, once every 3 weeks) combined with sintilimab (200 mg intravenous infusion, once every 3 weeks); 7. Received ≥2 cycles of post-progression treatment with bevacizumab plus sintilimab, lenvatinib, or regorafenib combined with PD-1 inhibitors; 8. Laboratory parameters: hemoglobin(Hb) ≥8.5 g/dL, white blood cell (WBC) count \>2000/mm³, platelet (PLT) count ≥75,000/mm³, absolute neutrophil count (ANC) \>1500/mm³, total bilirubin ≤30 μmol/L, serum albumin ≥30 g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 times the upper limit of normal (ULN), serum creatinine ≤1.5 times ULN, international normalized ratio (INR) ≤1.5, prothrombin time (PT) ≤18 seconds; 9. Availability of complete baseline data, treatment records, and follow-up data (including imaging assessments, laboratory tests, and clinical documentation). Exclusion Criteria: 1. Life expectancy ≤2 months; 2. Presence of intrahepatic cholangiocarcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-HCC malignancies; 3. Active concurrent malignancy or severe comorbid conditions; 4. First-line treatment with other anticancer therapies (chemotherapy, radiotherapy, surgery, or other interventions) concurrently; 5. Known hypersensitivity to study drugs.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
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