NCT06360042RecruitingPhase 2
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
Source: ClinicalTrials.gov · Last updated 22 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 111 (estimated)
- First submitted
- 27 Feb 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06360042
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 111
- From 1 Jan 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Previous or current presence of metastasis to central nervous system
Other illness
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- Known genetic or acquired hemorrhage or thrombotic tendency
- Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
- History of hepatic encephalopathy
Other
- Moderate-to-severe ascites with clinical symptoms
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.