NCT06196775Not yet recruitingPhase 2
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 25 Dec 2023
- Start date
- Jan 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Harbin Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06196775
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From Jan 2024 to the primary completion date, Jan 2026
- 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
- No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
- Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
- Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
Other illness
- Severe complications due to primary liver disease
- Autoimmune immune disease
- History of HIV
- The presence of any serious or uncontrolled systemic disease
Lab values
- Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
Other
- Prognent women
Who the study is looking for
- Histopathologically confirmed HCC
- Age 18-75 years old
- ECOG PS 0-1
- Child Pugh A-B7
- Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
- At least one measurable lesion (RECIST 1.1)
- Enough organ and bone marrow function
- Expected survival time≥12 weeks
- Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Harbin Medical University Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.