Table 1 Clinical trials combining lenvatinib and ICIs
Clinical trial registration number | Nature of the test | Basis for clustering | Treatment target | ORR | PFS(months) | OS(months) | Safety and adverse reactions | Number of persons included | References |
|---|---|---|---|---|---|---|---|---|---|
NCT03006926 | Phase Ib multicenter, single-arm,open-label study | Lenvatinib + Pembrolizumab | Unresectable hepatocellular carcinoma | 46% | 9.3 | 22 | TRAE Grade ≥ 3: 67% | 104 | [76] |
ChiCTR1900023914 | A single-arm, phase II trial | Lenvatinib + sintilimab/pembrolizumab/toripalimab/tislelizumab | Unresectable liver Cancer stage B or C HCC | 53.60% | 8.9 | 23.9 | TRAE Grade ≥ 3: 42.9% | 56 | [78] |
Prospective clinical trial | Lenvatinib vs. lenvatinib + nivolumab | HCC | 45.65% vs. 23.91% | NA | 92 | [79] | |||
A retrospective study | Lenvatinib + nivolumab vs. lenvatinib | Advanced hepatocellular carcinoma (aHCC) | 45.0% vs. 23.4% | 7.5 vs. 4.8 | 22.9 vs. 10.3 | HR 0.2,95% C.I. 0.1–0.7 | 87 | [80] | |
NCT04401800 | A multicenter, single-arm, phase 2 trial | Tislelizumab + lenvatinib | Unresectable hepatocellular carcinoma | 38.70% | 8.2 | 12: 88.6% | TRAE Grade ≥ 3: 28.1% | 64 | [81] |
A retrospective, unpaired, single-center study | Lenvatinib + anti‐PD‐1 antibodies | Advanced or unresectable hepatocellular carcinoma (HCC) | 28.10% | 8.4 | 17.2 | AE 79.5% | 210 | [82] | |
NCT03892577 | A retrospective study | Lenvatinib + anti‐PD‐1 antibodies | Unresectable hepatocellular carcinoma | 19.60% | 6.9 | 17.8 | AE Grade ≥ 3: 57.9 | 378 | [83] |
A retrospective study | Lenvatinib + anti‐PD‐1 antibodies vs. lenvatinib | Unresectable hepatocellular carcinoma | 41.5% vs. 20.0% | 8.0 vs. 3.0 | not reached vs. 13.0 | hypertension: 20% vs. 17.8% | 127 | [84] | |
A prospective trial | Synchronous + asynchronous of lenvatinib + PD‐1 inhibitor | HCC | 35.9% vs.19.8% | 10.5 vs. 3.6 | 24.6 vs. 14.8 | 40.2% vs. 41.3% | 213 | [85] | |
NCT04444167 | A phase Ib/II single-arm clinical trial | Time and dose of cardonizumab combined with lenvatinib | Advanced hepatocellular carcinoma (aHCC) | 6 mg/kg/2 weeks: 35.5% 15 mg/kg/3 weeks: 35.7% | 6 mg/kg/2 weeks: 8.6 months15 mg/kg/3 weeks: 9.8 months | 6 mg/kg/2 weeks: 27.1 months15 mg/kg/3 weeks: NA | NA | 59 | [86] |
A retrospective study | Lenvatinib + pembrolizumab/toripalimab/sintilimab/nivolumab/camrelizumab | Tumor occupation ≥ 50% volume of liver (TO ≥ 50%) or invasion in Vp4 | 20.20% | 6.6 | 11.4 | NA | 84 | [87] | |
NCT03892577 | A multicenter observational retrospective real-world study | ICI + lenvatinib vs. ICI + others (apatinib/regorafenib/bevacizumab/sorafenib/donafenib) | 13.8% vs. 3.7% | 6.1 vs. 3.4 | 22.1 vs. 21.3 | TRAE: 46.6% vs. 70.4% | 85 | [96] |