Actively Recruiting
Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma
Led by Peking Union Medical College Hospital · Updated on 2024-04-01
30
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. A single imaging assessment will be conducted, and successfully converted patients will proceed to surgical treatment, with pathological evaluation of intraoperative specimens. Post-surgery, patients will choose an appropriate adjuvant treatment based on prior treatment benefits, disease baseline, and personal preferences. Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment. Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and Lenvatinib±TACE/HAIC, with tumor imaging assessments every 3 cycles. Successfully converted patients will undergo surgery, followed by the selection of an appropriate adjuvant treatment based on prior treatment benefits, disease baseline, and personal preferences. Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment. Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and Lenvatinib±TACE/HAIC until disease progression or intolerable toxicity occurs, with a maximum treatment duration of 2 years. Efficacy assessment will use mRECIST and RECIST v1.1 criteria, and safety evaluation will follow CTCAE 5.0 standards. Adverse events will be recorded throughout the study, with a period extending to 60 days after treatment completion for serious adverse events or those related to Enfortumab Vedotin, and in some cases extended to 90 days post-treatment.
CONDITIONS
Official Title
Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before enrollment
- Age between 18 and 75 years, any gender
- Histologically or pathologically confirmed hepatocellular carcinoma or meeting clinical diagnostic criteria per AASLD
- BCLC stage C without distant or lymphatic metastasis, or BCLC stage B not eligible for curative surgery
- Measurable lesion(s) per RECIST 1.1 criteria (CT scan diameter thresholds as specified)
- No prior systemic anticancer therapy or local treatment for target lesions
- Child-Pugh score less than 7 and ECOG performance status 0-1
- At least one untreated measurable lesion per RECIST v1.1 or measurable lesion with progression after local treatment per mRECIST
- Expected survival greater than 12 weeks
- Use of medically approved contraception during the study and for 3 months after for fertile patients
- Negative pregnancy test within 7 days before study entry for relevant patients
- Adequate organ function as specified (hematology, liver, renal, coagulation)
You will not qualify if you...
- Histologically or cytologically confirmed fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma
- Prior local or systemic anti-tumor therapy
- History of hepatic encephalopathy or liver transplantation
- Significant pericardial effusion or symptomatic pleural effusion
- Clinically evident ascites
- Concurrent HBV and HCV infection
- Central nervous system metastasis or leptomeningeal metastasis
- Recent esophageal or gastric variceal bleeding
- Significant bleeding disorders or recent severe hemorrhagic events
- Recent arterial or venous thromboembolic events
- Uncontrolled hypertension or hypertensive crisis
- Symptomatic congestive heart failure or significant arrhythmias
- Severe bleeding tendency or coagulation disorders
- Recent use of high-dose aspirin or anticoagulants requiring INR monitoring
- History of gastrointestinal perforation, fistula, bowel obstruction, or chronic diarrhea
- Recent radiation therapy within 3 weeks before initial dose
- Interstitial lung disease or related lung conditions
- Active pulmonary tuberculosis or recent anti-TB treatment
- Active or history of autoimmune diseases requiring exclusion
- Use of immunosuppressive agents or corticosteroids above specified doses
- Active infection or unexplained fever above 38.5°C
- Evidence of lung fibrosis or severe lung impairment
- Congenital or acquired immunodeficiency
- Recent live vaccine administration
- History of substance, alcohol, or drug abuse
- Unable to take oral medication
- Any other factors deemed exclusionary by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hai-Tao Zhao
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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