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|Ref Type||Journal Article|
|Authors||Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li LQ, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang QR|
|Title||Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial.|
|Journal||Clinical cancer research : an official journal of the American Association for Cancer Research|
|Date||2020 Oct 21|
|Abstract Text||We assessed the efficacy and safety of camrelizumab (an anti-PD-1 monoclonal antibody) plus apatinib (a vascular endothelial growth factor [VEGFR]-2 tyrosine kinase inhibitor) in patients with advanced hepatocellular carcinoma (HCC).This non-randomized, open-label, multicenter, phase 2 study enrolled patients with advanced HCC who were treatment-naive or refractory/intolerant to first-line targeted therapy. Patients received intravenous camrelizumab 200 mg (for bodyweight ≥50 kg) or 3 mg/kg (for bodyweight <50 kg) every 2 weeks plus oral apatinib 250 mg daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC) per RECIST v1.1.Seventy patients in the first-line setting and 120 patients in the second-line setting were enrolled. As of January 10, 2020, the ORR was 34.3% (24/70, 95% CI 23.3-46.6) in the first-line and 22.5% (27/120, 95% CI 15.4-31.0) in the second-line cohort per IRC. Median progression-free survival in both cohorts was 5.7 months (95% CI 5.4-7.4) and 5.5 months (95% CI 3.7-5.6), respectively. The 12-month survival rate was 74.7% (95% CI 62.5-83.5) and 68.2% (95% CI 59.0-75.7), respectively. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 147 (77.4%) of 190 patients, with the most common being hypertension (34.2%). Serious TRAEs occurred in 55 (28.9%) patients. Two (1.1%) treatment-related deaths occurred.Camrelizumab combined with apatinib showed promising efficacy and manageable safety in patients with advanced HCC in both the first-line and second-line setting. It might represent a novel treatment option for these patients.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||hepatocellular carcinoma||not applicable||Camrelizumab + Rivoceranib||Phase II||Actionable||In a Phase II trial (RESCUE), combined Camrelizumab (SHR-1210) and Rivoceranib (apatinib) treatment resulted in an objective response rate (ORR) of 34.3% (24/70), disease control rate (DCR) of 77.1% (54/70), and median progression-free survival (mPFS) of 5.7 months in previously untreated advanced hepatocellular carcinoma patients, and patients given this combination as second-line therapy demonstrated an ORR of 22.5% (27/120), DCR of 75.8% (91/120), and mPFS of 5.5 months (PMID: 33087333; NCT03463876).||33087333|