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New treatment option for Hepatocellular Carcinoma
Official title Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06406634
What this study is testing
What is Cadonilimab?
Cadonilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as AK104.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The written informed consent form should be signed before a subject participates in the trial；
- Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of...
- According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging...
- Child-Pugh A or B；
- at least 1 measurable lesion according to RECIST v1.1；
You likely can't join if
- Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been...
- Recurrence of previous hepatocellular carcinoma；
- Autoimmune hepatitis (requires liver puncture)
- Have a history of hepatic encephalopathy or liver transplantation;
- Diffuse liver cancer;
- Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage;
See the full eligibility criteria
Who can join
- The written informed consent form should be signed before a subject participates in the trial；
- Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)；
- According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as...
- Child-Pugh A or B；
- at least 1 measurable lesion according to RECIST v1.1；
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1；
- Adequate organ and marrow function, as defined below； 1) Absolute neutrophil count (ANC) ≥1.5x109/L without granulocyte colony-stimulating factor in the last 14 days； 2) Platelets ≥75×109/L without transfusion in the...
- a woman of childbearing potential (WOCBP) who is sexually active with a nonsterilized male partner must have a negative pregnancy test at the Screening visit (within 3 days before the first dose of the investigational...
- If there is a risk of conception, all people (male or female) will be required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after administration of the...
What rules you out
- Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
- Recurrence of previous hepatocellular carcinoma；
- Autoimmune hepatitis (requires liver puncture)
- Have a history of hepatic encephalopathy or liver transplantation;
- Diffuse liver cancer;
- Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage;
- History of kidney disease or nephrotic syndrome;
- Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose...
- Any arterial/venous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or...
- Presence of any life-threatening bleeding events;
- consecutive dosing of aspirin or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function before the first dose;
- Uncontrolled hypertension (systolic greater than 140 mmHg or diastolic greater than 90 mmHg) after the optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
- Symptomatic congestive cardiac failure (NYHA Class II-IV). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected Qtc \> 500 ms (calculated using Fridericia formula) during...
- History of gastrointestinal perforation and/or fistula, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive...
- Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose or having unhealed wounds, ulcers, or fractures. Receipt of tissue biopsy or other minor surgeries within 7 days...
- History or current experience of pulmonary fibrosis and such lung diseases as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired lung function.
- Acute or chronic active hepatitis B or C infection
- Active tuberculosis (TB), currently receiving anti-tuberculosis treatment or received such therapy within 1 year before the first dose.
- Human immunodeficiency virus (HIV) infected (HIV 1/2 antibody positive) and known syphilis infection requiring treatment.
- Active or poorly clinically controlled serious infections. Severe infections within 4 weeks before the first dose, including but not limited to hospitalization caused by infection, bacteremia, or severe pneumonia...
- Receipt of immunosuppressants within 4 weeks before the first dose;
- Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned to receive a live attenuated vaccine during the study;
- Receipt of systemic treatment with traditional Chinese medicines with cancer indications or immunomodulators (including thymosin, interferon, and interleukin, barring local use for controlling pleural fluid or ascites)...
- Prior exposure to any agent targeting T cell costimulation or immune checkpoint pathways (e.g., anti-PD 1, anti-PD L1, anti-PD L2, anti-CTLA 4, anti CD137 or anti-OX40 antibody, etc).
- Known allergy or reaction to any component of the Cadonilimab formulation;
- Receipt of treatment in other clinical trials within 4 weeks before the first dose;
- Pregnant or breastfeeding female patients;
- Considered ineligible for participating in the trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.