Combining immune and anti-angiogenic therapies for advanced liver cancer treatment
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
This study is testing three different combinations of immune and anti-cancer treatments to see which one works best for people with advanced liver cancer that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Adebrelimab, Bevacizumab, Camrelizumab, Apatinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06360042 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of three different combinations of treatments for patients with unresectable hepatocellular carcinoma (HCC). Participants will receive either Adebrelimab with Apatinib, Adebrelimab with Bevacizumab, or Camrelizumab with Apatinib as their first-line therapy. The study is multicenter, randomized, and open-label, aiming to determine which combination is most effective for this patient population. The trial includes patients with advanced stages of HCC who have not received prior systemic therapy.
Who should consider this trial
Good fit: Ideal candidates are adults with locally advanced or metastatic unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Not a fit: Patients with other active malignancies, certain types of liver cancer, or significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and anti-angiogenic agents, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Zhou — Peking University Cancer Hospital & Institute
- Study coordinator: Jun Zhou
- Email: Joelbmu@126.com
- Phone: 13366152815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.