Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSong Peng
About this trial
Patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who progressed after prior systemic therapy (targeted ± immunotherapy) are enrolled. Primary endpoint: objective response rate (ORR). Planned enrollment: 47 subjects. Eligible patients receive adebrelimab + apatinib.
After informed consent and screening, treatment starts: Adebrelimab 1200mg IV on D1, Q3W; apatinib 250mg oral QD, continuous. 21-day cycle. Treatment continues until intolerable toxicity, consent withdrawal, RECIST v1.1-proven progression (may continue if clinically beneficial), or protocol-specified criteria (whichever first).
Safety follow-up on D1 of each cycle; imaging every 2 cycles (6-8 weeks) for efficacy. Post-treatment: continued safety and survival follow-up.
Eligibility criteria
Qualifiers
Patients voluntarily participate in this study and sign the informed consent form;
Aged ≥ 18 years (calculated as of the date of signing the informed consent form), male or female;
Pathologically or clinically confirmed hepatocellular carcinoma (HCC);
Have previously received at least one or more lines of systemic therapy (targeted therapy with or without immunotherapy);
Disqualifiers
Previously received PD-L1 immunotherapy or apatinib targeted therapy;
No clear tumor-feeding artery identifiable by angiography;
Known cholangiocellular carcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; having other active malignant tumors (except HCC) within 5 years or concurrently. Locally cured tumors such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment;
Allergic to the investigational drugs;
Trial design
Treatments tested in this trial
- Adebrelimab + Apatinib
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Song Peng
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Sponsor institution
Source ClinicalTrials.gov