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New treatment option for Cadonilimab and Lenvatinib
Official title Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06215651
What this study is testing
What is Cadonilimab lenvatinib?
Cadonilimab lenvatinib is an investigational medicine, being studied as a potential treatment for cadonilimab and lenvatinib.
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 a single-arm, open-label, exploratory clinical trial designed to assess the effectiveness and safety of the combination therapy of Cadonilimab and Lenvatinib for conversion treatment in unresectable hepatocellular carcinoma. Eligible patients, meeting the inclusion criteria and providing informed consent, will undergo 3-4 cycles of Cadonilimab and Lenvatinib conversion therapy.
- 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
- Participants must sign a written informed consent form before enrollment. Age \>18 and ≤75 years, both genders are eligible. Patients with...
- BCLC stage C without distant or lymphatic metastasis, or BCLC stage B ineligible for curative surgical treatment.
- Presence of measurable lesions (according to RECIST 1.1 criteria, CT scan long diameter ≥10 mm for non-lymph node lesions, CT scan short diameter ≥15...
- No prior systemic anticancer therapy. No prior local treatment for target lesions, including TAE, TACE, TARE, surgery, ablation, PEI, or radiotherapy.
- Child-Pugh score \<7. ECOG PS score: 0-1. At least one untreated measurable lesion according to RECIST v1.1, or a measurable lesion with confirmed...
You likely can't join if
- Previously histologically/cytologically confirmed hepatocellular carcinoma with fibrolamellar components, sarcomatoid hepatocellular carcinoma...
- Prior local or systemic anti-tumor therapy. History of hepatic encephalopathy. History of liver transplantation. Clinically significant pericardial...
- Clinically evident ascites defined as detectable on physical examination or requiring drainage during screening.
- Concurrent HBV and HCV infection (HCV RNA negative patients with a history of HCV infection are considered uninfected).
- Central nervous system metastasis or leptomeningeal metastasis. History of esophageal or gastric variceal bleeding due to portal hypertension in the...
- Patients with any bleeding diathesis signs or history, experiencing any bleeding or hemorrhagic events ≥CTCAE Grade 3 within the first 4 weeks before...
See the full eligibility criteria
Who can join
- Participants must sign a written informed consent form before enrollment. Age \>18 and ≤75 years, both genders are eligible. Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC) or...
- BCLC stage C without distant or lymphatic metastasis, or BCLC stage B ineligible for curative surgical treatment.
- Presence of measurable lesions (according to RECIST 1.1 criteria, CT scan long diameter ≥10 mm for non-lymph node lesions, CT scan short diameter ≥15 mm for lymph node lesions).
- No prior systemic anticancer therapy. No prior local treatment for target lesions, including TAE, TACE, TARE, surgery, ablation, PEI, or radiotherapy.
- Child-Pugh score \<7. ECOG PS score: 0-1. At least one untreated measurable lesion according to RECIST v1.1, or a measurable lesion with confirmed progression after local treatment (e.g., radiofrequency ablation...
- Expected survival \>12 weeks. Non-surgically sterilized or premenopausal female patients must use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the...
- Adequate organ function, excluding any blood component and growth factor use within 14 days:
- Hematology: ANC ≥1.5×10\^9/L, PLT ≥50×10\^9/L, HGB ≥90g/L. Liver function: TBIL ≤3×ULN, ALT and AST ≤5×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN, and must be stable for at least 1 week after routine liver protection...
- Renal function: Cr ≤1.5×ULN or creatinine clearance ≥50 mL/min (using the standard Cockcroft-Gault formula), and urine protein \<2+; for patients with baseline urine protein ≥2+, a 24-hour urine collection and...
- Coagulation function: INR and APTT ≤1.5×ULN; for people receiving anticoagulant therapy, PT and INR should be within the planned range.
What rules you out
- Previously histologically/cytologically confirmed hepatocellular carcinoma with fibrolamellar components, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- Prior local or systemic anti-tumor therapy. History of hepatic encephalopathy. History of liver transplantation. Clinically significant pericardial effusion requiring drainage or clinically symptomatic pleural effusion.
- Clinically evident ascites defined as detectable on physical examination or requiring drainage during screening.
- Concurrent HBV and HCV infection (HCV RNA negative patients with a history of HCV infection are considered uninfected).
- Central nervous system metastasis or leptomeningeal metastasis. History of esophageal or gastric variceal bleeding due to portal hypertension in the first 6 months before the initial dose. Participants must have...
- Patients with any bleeding diathesis signs or history, experiencing any bleeding or hemorrhagic events ≥CTCAE Grade 3 within the first 4 weeks before the initial dose.
- Occurrence of arterial or venous thromboembolic events in the first 6 months before the initial dose, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary...
- Uncontrolled hypertension, with systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg after optimal medical treatment, hypertensive crisis, or a history of hypertensive encephalopathy.
- Symptomatic congestive heart failure (New York Heart Association Class II-IV) or echocardiographic left ventricular ejection fraction (EF) \ 100 beats/min, a history of congenital long QT syndrome, or a corrected QT...
- Severe bleeding tendency or coagulation disorders, or receiving thrombolytic therapy. Currently using or recently used (within 10 days before the first dose of study treatment) aspirin (\>325 mg/day) or anticoagulants...
- History of gastrointestinal perforation and/or fistula within the first 6 months before the initial dose, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive...
- Received radiation therapy within the first 3 weeks before the initial dose. Patients who received radiation therapy more than 7 days before the first dose can be enrolled. Presence of interstitial lung disease or...
- Active pulmonary tuberculosis (TB), receiving anti-TB treatment, or having received anti-TB treatment within the past 1 year before the initial dose.
- people with any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, vasculitis, nephritis...
- people using immunosuppressive agents, either systemic or locally absorbable steroids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), and still continuing within the last 2 weeks before...
- people with active infection or unexplained fever \>38.5°C during screening or within the first 4 weeks before the initial dose (people with fever related to tumor-induced fever can be included according to the...
- Patients with objective evidence of past or present lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of lung function.
- people with congenital or acquired immunodeficiency, such as HIV infection. people who have not received live vaccines within 4 weeks before the study medication or may receive live vaccines during the study period.
- people with a known history of substance abuse, alcohol abuse, or drug abuse. Patients unable to take oral medication. The investigator deems it necessary to exclude people from this study. For instance, based on the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.