Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
At least one measurable lesion per RECIST v1.1
Disqualifiers
Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
Moderate-to-severe ascites with clinical symptoms
History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Adebrelimab plus Apatinib
DrugAdebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
Adebrelimab plus Bevacizumab
DrugAdebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
Camrelizumab plus Apatinib
Drugcamrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily
Treatment groups
111 Participants
are divided into 3 treatment groupsGroup A: 1Experimental treatment 1 intervention
Group B: 2Experimental treatment 1 intervention
Group C: 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-month overall survival rate
Time frame
Up to approximately 3 yearsSecondary outcomes
1
ORR
Assessed by the investigator per RECIST v1.1 criteria
Time frame
Up to approximately 3 years2
DCR
Assessed by the investigator per RECIST v1.1 criteria
Time frame
Up to approximately 3 years3
DoR
Assessed by the investigator per RECIST v1.1 criteria
Time frame
Up to approximately 3 years4
TTR
Assessed by the investigator per RECIST v1.1 criteria
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov