SHR-1701 Plus Apatinib for Second-Line Treatment in Targeted-Immune Pretreated Advanced Hepatocel… (NCT07749859) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SHR-1701 Plus Apatinib for Second-Line Treatment in Targeted-Immune Pretreated Advanced Hepatocellular Carcinoma
China80 participantsStarted 2026-08
Plain-language summary
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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. ECOG performance status of 0 or 1;
. Expected survival ≥ 12 weeks;
. Child-Pugh Class A (score 5-6);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From first dose until disease progression, death, or 24 months, whichever occurs first. Tumor response assessed every 6-9 weeks per RECIST v1.1.
Trial details
NCT IDNCT07749859
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Adequate organ and bone marrow function as defined below (tested within 14 days prior to initiation of study treatment):
Exclusion criteria
. 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;
. Uncontrolled hypertension (persistent blood pressure ≥140/90 mmHg despite medical treatment), persistent proteinuria ≥2+ or uncorrected 24-hour urinary protein ≥1.0 g;
. Severe cardiovascular diseases: myocardial infarction (MI), unstable angina, NYHA Class III-IV heart failure, clinically significant arrhythmia, QTcF interval ≥470 ms within the preceding 6 months, or recent arterial/venous thromboembolic events;
. Recent surgical procedures or unhealed wounds: major surgery performed within 4 weeks prior to enrollment with unhealed incision; gastrointestinal perforation or fistula occurring within 6 months prior to enrollment;
. Active infections: bacterial or fungal infections requiring intravenous antibiotics, active tuberculosis; high HBV-DNA replication without antiviral therapy initiated; uncontrolled HIV infection (e.g., CD4 count \<200/μL or detectable viral load) or history of opportunistic infections;