NCT06360042 Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
| NCT ID | NCT06360042 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | Unresectable Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-03-31 |
Trial Parameters
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Brief 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.
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
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