This clinical study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection (SHR-1701) combined with apatinib in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after first-line targeted combined immunotherapy, and provide clinical evidence for the second-line treatment of advanced HCC. A total of 80 patients with radiologically or pathologically confirmed advanced/unresectable hepatocellular carcinoma with disease progression after prior first-line targeted-immunotherapy will be enrolled within 2.5 years. All enrolled patients will receive intravenous infusion of SHR-1701 at 30 mg/kg every 3 weeks in combination with oral apatinib 250 mg once daily; treatment will be maintained until disease progression or intolerable adverse toxicity occurs. The primary study endpoint is objective response rate (ORR).
Aged 18-75 years, male or female; signed informed consent form with good compliance;
Patients with histologically confirmed hepatocellular carcinoma or meeting clinical diagnostic criteria, currently unresectable or metastatic;
Prior receipt of first-line combined targeted and immunotherapy with subsequent disease progression or intolerance;
At least one measurable lesion meeting the criteria of RECIST v1.1;
History of severe hypersensitivity or irreversible toxic reactions to similar PD-L1 agents or VEGFR-2 TKIs;
Child-Pugh Class B or C, refractory ascites requiring paracentesis at least weekly, Grade ≥2 hepatic encephalopathy, or MELD score >12 (optional, subject to institutional SOPs);
High bleeding risk: Grade ≥3 gastrointestinal hemorrhage, perforation, active ulcer or uncontrolled bleeding diathesis within the past 6 months; untreated medium-to-large varices or high-risk signs identified on EGD without completed prophylactic intervention; clinical indication for potent anticoagulants or dual antiplatelet therapy that cannot be discontinued or substituted (aspirin ≤100 mg daily may be permitted at the Investigator's discretion);
Prior treatment with apatinib or PD-L1 monoclonal antibody immune checkpoint inhibitors;
Single group
Retlirafusp alfa Injection, apatinib
DrugAll enrolled patients will receive intravenous infusion of SHR-1701 at 30 mg/kg every 3 weeks in combination with oral apatinib 250 mg once daily;TACE intervention is permitted during treatment, which can only be conducted after the first efficacy assessment. Treatment will be continued until disease progression, intolerable toxicity, or other treatment discontinuation criteria are met.
Objective Response Rate (ORR)
It is defined as the proportion of participants achieving complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified RECIST (mRECIST).
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