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Trial Title:
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
NCT ID:
NCT06360042
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab plus Apatinib
Description:
Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
Arm group label:
1
Intervention type:
Drug
Intervention name:
Adebrelimab plus Bevacizumab
Description:
Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
Arm group label:
2
Intervention type:
Drug
Intervention name:
Camrelizumab plus Apatinib
Description:
camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily
Arm group label:
3
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- ECOG Performance Status of 0 or 1
- Child-Pugh class of A5 to B7
- Adequate organ function
Exclusion Criteria:
- 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
- Known genetic or acquired hemorrhage or thrombotic tendency
- Thrombosis or thromboembolic event within 6 months prior to the start of study
treatment
- Hypertension that can not be well controlled through antihypertensive drugs Factors
to affect oral administration
- History of hepatic encephalopathy
- Previous or current presence of metastasis to central nervous system
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhou
Phone:
13366152815
Email:
Joelbmu@126.com
Start date:
January 1, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06360042
