✦ Cancer Clinical Trials

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Hepatocellular Carcinoma

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Oct 12 – Oct 19, 2026

Perioperative Camrelizumab and Apatinib for High-Risk Resectable Hepatocellular Carcinoma: A Phase II Study.
▼MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This single-arm phase II trial evaluated perioperative camrelizumab plus apatinib in 31 patients with high-risk resectable hepatocellular carcinoma, administering four neoadjuvant cycles followed by surgical resection and up to one year of adjuvant therapy. The primary endpoint was major pathological response (MPR), achieved in 46.2% of the 26 patients who underwent surgery, with median disease-free survival of 24.1 months and median progression-free survival of 18.3 months. Grade 3 or higher adverse events occurred in 12.9% of patients during the neoadjuvant phase. The authors concluded that this perioperative regimen demonstrated promising efficacy and manageable safety in this high-risk resectable HCC population.
10.1002/mco2.70861

Oct 05 – Oct 12, 2026

Clinical impact of early enteral nutrition support on gastrointestinal function, nutritional status, liver function, and immune function in liver cancer patients.
▼FRONT MED-LAUSANNE · Q1 JOURNAL - RANK #61/332
This randomized controlled trial evaluated early enteral nutrition (EEN) versus total parenteral nutrition (TPN) in 80 primary liver cancer patients treated between December 2022 and December 2023, with 40 patients per group receiving isocaloric and isonitrogenous nutritional support after surgery. The primary outcome was change in serum albumin from baseline to postoperative day 7, with secondary outcomes including gastrointestinal recovery, nutritional markers (DAO, PA), liver function markers (ChE, AST, ALT), immune markers (CD4+, CD8+, CD4+/CD8+ ratio), adverse reactions, and exploratory clinical outcomes. The EEN group showed significantly higher postoperative ALB levels (30.5±2.5 vs. 26.2±2.7 g/L; mean difference 4.3 g/L, 95% CI: 2.8-5.8, p<0.001), faster gastrointestinal recovery (all p<0.001), and significant group×time interactions for all nutritional, liver, and immune markers (all p<0.001). EEN also had shorter hospital stay (12.5±3.2 vs. 16.8±4.1 days, p<0.001) and fewer adverse reactions (2.5% vs. 20.0%, p=0.013), with no significant differences in infection, readmission, or liver failure rates.
10.3389/fmed.2026.1769787

First-line durvalumab and tremelimumab in poor-prognosis unresectable hepatocellular carcinoma: Phase IIIb single-arm SIERRA study.
▼J HEPATOL · Q1 JOURNAL - RANK #3/147TOP-TIER
The phase IIIb single-arm SIERRA study evaluated first-line STRIDE (tremelimumab plus durvalumab) in 111 adults with unresectable hepatocellular carcinoma and poor prognostic factors, including Child-Pugh B7/B8 (n=44), ECOG PS 2 (n=47), or Vp4 portal vein thrombosis (n=20). Participants received tremelimumab 300 mg plus durvalumab 1500 mg once, then durvalumab 1500 mg every 4 weeks until progression, unacceptable toxicity, or withdrawal. The incidence of Grade 3/4 treatment-related adverse events within 6 months was 19.8% (95% CI 12.9-28.5), and the objective response rate was 14.4% (95% CI 8.5-22.4), with cohort-specific ORRs of 6.8%, 21.3%, and 15.0%, respectively. The authors concluded that STRIDE showed a favourable risk-benefit profile in this underrepresented poor-prognosis population.
10.1016/j.jhep.2026.10.002

Sep 14 – Sep 21, 2026

Biomarkers associated with efficacy of first-line nivolumab vs. sorafenib in advanced hepatocellular carcinoma: results from the CheckMate 459 phase III trial.
▼JHEP REP · Q1 JOURNAL - RANK #15/147
This exploratory biomarker analysis of the phase 3 CheckMate 459 trial evaluated first-line nivolumab versus sorafenib in advanced hepatocellular carcinoma using whole-exome sequencing, RNA sequencing, immunohistochemistry, and serology. Among evaluable patients, baseline tumor mutational burden was not predictive of survival with nivolumab, whereas unaltered Wnt/β-catenin pathway, high T-cell inflammation gene signature score, and programmed death ligand 1 combined positive score ≥10 were associated with improved overall survival with nivolumab versus sorafenib (HR 0.66, 95% CI 0.47-0.91; HR 0.68, 95% CI 0.47-0.98; HR 0.55, 95% CI 0.33-0.93, respectively). Circulating biomarkers including high interferon-γ, low pro-collagen 11, and low granulocytic myeloid-derived suppressor cells also correlated with improved nivolumab efficacy. The authors conclude that these candidate biomarkers support further studies to identify advanced HCC patients who may benefit from programmed death-1 inhibition.
10.1016/j.jhepr.2026.102038

Aug 31 – Sep 07, 2026

Association between gut microbiota characteristics and therapeutic efficacy of multimodal combination therapy in hepatocellular carcinoma with portal vein tumor thrombus: a secondary analysis of a prospective phase II trial.
▼FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This secondary analysis of a prospective phase II trial investigated gut microbiota features associated with therapeutic response in 23 treatment-naïve hepatocellular carcinoma patients with portal vein tumor thrombus receiving SBRT plus cadonilimab and lenvatinib. Paired fecal samples were collected before treatment and after 3 cycles, with 16S rRNA sequencing performed. Responders (n=10) showed higher Faith’s phylogenetic diversity (P=0.0178), while genus-level analysis identified a taxa absent in responders but present in 6/13 non-responders (P=0.0179), yielding an AUC of 0.731. The study concludes that selected baseline microbial features, particularly the exploratory non-response-associated genus, may predict therapeutic response and warrant validation in larger studies.
10.3389/fimmu.2026.1864941

Lenvatinib versus Sorafenib in First-Line Treatment of Older Patients with Unresectable Hepatocellular Carcinoma: A Subgroup Analysis of the REFLECT Trial.
▼LIVER CANCER · Q1 JOURNAL - RANK #11/147
This post-hoc subgroup analysis of the open-label, phase 3 REFLECT trial evaluated the efficacy and safety of lenvatinib versus sorafenib in older patients (≥65 and ≥75 years) with unresectable hepatocellular carcinoma (uHCC). The study analyzed data from 401 patients aged ≥65 years (208 lenvatinib, 193 sorafenib), who were randomly assigned 1:1 to receive lenvatinib or sorafenib. Results showed a median overall survival of 14.6 months for lenvatinib versus 13.4 months for sorafenib (HR: 0.844), a median progression-free survival of 7.4 versus 5.4 months (HR: 0.571), and objective response rates of 42.8% versus 14.5%, respectively. The authors concluded that consistent with the overall trial population, lenvatinib showed improved efficacy versus sorafenib, supporting it as an option for older patients with uHCC.
10.1159/000553375

Aug 24 – Aug 31, 2026

Atezolizumab-Bevacizumab with or without Cisplatin-based HAIC for Unresectable HCC: A Randomized Phase 2 Trial.
▼JHEP REP · Q1 JOURNAL - RANK #15/147
This randomized phase 2 trial evaluated whether adding sequential cisplatin-based hepatic arterial infusion chemotherapy (HAIC) to atezolizumab-bevacizumab (ATZ/BEV) improves outcomes in unresectable hepatocellular carcinoma (HCC). In a multicenter, open-label design, 70 patients were randomized 1:1 to receive cisplatin HAIC before ATZ/BEV or ATZ/BEV alone. The primary endpoint, objective response rate (ORR), was numerically higher in the combination arm but not statistically significant (45.7% vs 28.6%, p=0.095). Exploratory analyses showed improved progression-free survival (8.3 vs 6.6 months, HR 0.53, p=0.036) without added safety concerns, warranting phase 3 evaluation.
10.1016/j.jhepr.2026.102002

On-demand transarterial chemoembolisation combined with atezolizumab and bevacizumab in patients with untreated hepatocellular carcinoma (TALENTACE): a multicentre, randomised, open-label, phase 3 trial.
▼LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
This multicenter, randomized, open-label, phase 3 trial (TALENTACE) evaluated on-demand transarterial chemoembolisation plus atezolizumab and bevacizumab versus on-demand TACE alone in 342 patients with untreated, unresectable hepatocellular carcinoma. Patients were randomized 1:1 across 40 centers in China and Japan, with primary endpoints of TACE progression-free survival and overall survival in the intention-to-treat population. At a median follow-up of 26.25 months, median TACE-PFS was 11.30 months with combination therapy versus 7.03 months with TACE alone (HR 0.71, 95% CI 0.55-0.92; p=0.0089), while overall survival data remained immature (HR 0.96). The combination significantly improved TACE-PFS with manageable toxicity, and overall survival follow-up is ongoing.
10.1016/S2468-1253(26)00212-8

Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.
▼LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This phase 3, randomized, open-label, sponsor-blinded trial evaluated the efficacy and safety of durvalumab and tremelimumab (STRIDE), with or without lenvatinib, combined with transarterial chemoembolisation (TACE) in patients with embolisation-eligible hepatocellular carcinoma (HCC). A total of 760 participants were randomly assigned to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE alone. The primary endpoint of progression-free survival was met, with a median of 13.0 months for the STRIDE plus lenvatinib plus TACE group versus 9.8 months for TACE alone (HR 0.70; p=0.0007). The authors conclude that the STRIDE-based regimen represents a potential new treatment option for this patient population, with ongoing follow-up for overall survival.
10.1016/S1470-2045(26)00278-0

Aug 17 – Aug 24, 2026

Sorafenib plus hepatic arterial infusion chemotherapy versus sorafenib plus transarterial chemoembolization in advanced hepatocellular carcinoma: a phase III trial and biomarker analyses.
▼J NATL CANCER CTR · Q1 JOURNAL - RANK #31/326
This phase III randomized controlled trial compared sorafenib plus hepatic arterial infusion chemotherapy (SoraHAIC) to sorafenib plus transarterial chemoembolization (SoraTACE) in 207 patients with advanced hepatocellular carcinoma, with overall survival (OS) as the primary endpoint. Patients were randomly assigned 2:1 to receive SoraHAIC (n=141) or SoraTACE (n=66). SoraHAIC significantly improved median OS (15.7 vs. 11.2 months; HR 0.58, 95% CI 0.42-0.80, p<0.001) and progression-free survival (7.2 vs. 4.1 months; HR 0.48, 95% CI 0.35-0.65, p<0.001) compared with SoraTACE. Grade 3-4 treatment-related adverse events were lower with SoraHAIC (39.3% vs. 56.7%, p=0.023). The study concludes that SoraHAIC significantly improves OS over SoraTACE, with biomarker analyses suggesting patients with high PFKM expression may benefit more from SoraTACE.
10.1016/j.jncc.2026.04.002

Liver resection after atezolizumab and bevacizumab versus maintenance therapy for locally advanced hepatocellular carcinoma (TALENTOP): a multicentre, open-label, randomised, phase 3 trial.
▼LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
This multicentre, open-label, randomised, phase 3 trial (TALENTOP) evaluated liver resection plus maintenance atezolizumab-bevacizumab versus maintenance alone in 201 patients with advanced hepatocellular carcinoma and macrovascular invasion who responded to induction systemic therapy. Patients were randomly assigned to surgery followed by 12 months of atezolizumab-bevacizumab or to maintenance therapy until loss of benefit or toxicity. At a median follow-up of 18.4 months, median time to treatment failure was 20.4 months in the surgery group versus 11.8 months in the maintenance group (hazard ratio 0.60, 95% CI 0.39-0.91; p=0.015). Grade 3-4 treatment-related adverse events occurred in 39% versus 21% of patients, with two treatment-related deaths in the surgery group. The authors concluded that liver resection improved time to treatment failure and may offer additional benefit in this population.
10.1016/S0140-6736(26)01252-3

Efficacy and safety of pain management in perioperative period of TACE in patients with HCC: a single-center, parallel-group, randomized trial.
▼FRONT MED-LAUSANNE · Q1 JOURNAL - RANK #61/332
This single-center, parallel-group randomized trial evaluated proactive perioperative pain management using hydromorphone patient-controlled analgesia (PCA) versus standard-care subcutaneous morphine (SCM) in 110 patients with hepatocellular carcinoma undergoing transarterial chemoembolization (TACE). The modified intention-to-treat population included 105 patients (PCA, n=51; SCM, n=54), with the primary outcome being the 24-hour Numerical Rating Scale (NRS) pain score. At 24 hours, the mean NRS score was significantly lower in the PCA group (0.39±0.67 vs. 1.04±1.43; mean difference, -0.64; 95% CI, -1.07, -0.22; p=0.004), and the PCA group also had lower 48-hour pain AUC and less rescue opioid use (3.9% vs. 50.0%; p<0.001), but experienced more dizziness (31.4% vs. 3.7%; p<0.001). The authors conclude that hydromorphone PCA reduced short-term pain burden and rescue opioid requirements after TACE but increased dizziness, and the modest absolute differences in NRS scores warrant individualized safety monitoring.
10.3389/fmed.2026.1862804

Baseline circulating and tumor γδ T cells and early circulating CD8⁺PD1⁺ expansion predict response to Atezolizumab-bevacizumab in HCC.
▼CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prospective study evaluated circulating and tumor immune biomarkers predicting outcomes in 31 patients with hepatocellular carcinoma (HCC) receiving first-line Atezolizumab-Bevacizumab (AtezoBev). Patients underwent sequential PBMC immunophenotyping, cytokine profiling, and whole-blood RNA sequencing, with tumor RNA-seq data from clinical trials (GO30140/IMbrave150; 209 AtezoBev, 58 sorafenib) and 163 MSI-H colorectal cancer patients used for validation. High baseline circulating γδ T cells predicted disease control (p=0.006) and longer progression-free survival (PFS) (p=0.02); high intratumoral γδ T signature was associated with better response (p<0.01), PFS (p<0.001), and overall survival (p=0.003) only in AtezoBev-treated patients. Early CD8⁺PD-1⁺ expansion correlated with longer PFS (p=0.03), while CD8⁺TIGIT⁺ increase was linked to shorter PFS (p=0.04), with transcriptomic confirmation of IFN-γ signaling induction at 3 weeks. The authors conclude that baseline γδ T cells and early CD8⁺PD-1⁺ expansion predict favorable outcomes, whereas CD8⁺TIGIT⁺ increase indicates resistance.
10.1158/1078-0432.CCR-26-1102