RESCUE Trial Camrelizumab + apatinib

Background

Phase II, nonrandomized, open-label, multicenter trial of camrelizumab plus apatinib in advanced hepatocellular carcinoma, enrolling both treatment-naïve patients (first-line cohort) and those refractory/intolerant to prior first-line targeted therapy (second-line cohort), with a high proportion of HBV infection.

Interventions and follow up

Regimen: camrelizumab 200 mg (or 3 mg/kg if <50 kg) IV every 2 weeks + apatinib 250 mg PO daily, in 4-week cycles
Cohorts: first-line and second-line
Primary endpoint: objective response rate by independent review (RECIST 1.1)
Median follow up: 15.9–17.1 months

Results

ORR: 34.3% (first-line) vs 22.5% (second-line)
12-mo OS: 74.7% (first-line) vs 68.2% (second-line)
Responses: durable across both cohorts

Adverse events

Any-grade common AEs: hypertension 72.6%, AST increase 63.2%, proteinuria 61.6%, hyperbilirubinemia 61.6%
Grade ≥3 immune-related AEs: 14 patients (7.4%); safety profiles similar between cohorts

Conclusions

Camrelizumab plus apatinib produced a high objective response rate, durable responses, and prolonged survival with a manageable safety profile in advanced HCC enriched for HBV infection, in both first- and second-line settings.

Key Limitations

Nonrandomized, open-label, single-country (China) study with no comparator arm. HBV-predominant population may limit generalizability. Single-arm cohorts preclude direct efficacy comparison vs standard of care.

Clinical Context

Provided early evidence for PD-1 inhibitor plus VEGFR-TKI combinations in HCC. Camrelizumab-apatinib (rivoceranib) was later studied in the randomized phase III CARES-310 trial, which showed OS benefit over sorafenib; the combination is approved in China and reviewed by ASCO/ESMO frameworks.

References