NCT04444167CompletedPhase 1/2
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma
An Open-Label Multi-Center Phase Ib/II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in Combination With Lenvatinib As the First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 25 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 21 Jun 2020
- Start date
- 7 Jul 2020
- Primary completion date
- 20 Nov 2023
- Lead sponsor
- Akeso
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04444167
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 59
- From 7 Jul 2020 to the primary completion date, 20 Nov 2023
- 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
- Occurred arteriovenous thromboembolic events within 6 months before the first administration.
- Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
Other illness
- History of hepatic encephalopathy or liver transplantation.
- Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
- Inadequately controlled arterial hypertension.
- Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
- Severe infections.
Lab values
- Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
Other
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- Clinical significance of hydrothorax, ascites or pericardial effusion.
- Central nervous system metastases and/or carcinomatous meningitis.
- Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
- Unable to receive an enhanced CT or MRI scan of the liver.
Who the study is looking for
- Signed written informed consent form voluntarily.
- Histologically or cytologically documented hepatocellular carcinoma.
- BCLC stage C, and non-resectable BCLC stage B .
- At least one measurable lesion according to RECIST criteria.
- ECOG of 0 or 1.
- Adequate organ function.
- Estimated life expectancy of ≥3 months.
- For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.
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 |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.