BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies
ClinicalTrials.gov ID: NCT05803928
What this study is testing
What is lenvatinib + anti-PD-1 antibodies?
lenvatinib + anti-PD-1 antibodies is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma.
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
- Lenvatinib is an oral multi-target receptor tyrosine kinase inhibitor (TKI) inhibitor that mainly inhibits the Endothelial growth factor receptor (VEGFR) VEGFR-1,2,3; Fibroblast growth factor receptor, FGFR) FGFR-1,2,3,4; Platelet-derived growth factor receptor (PDGFR) PDGFRα; The kinases RET and KIT, thereby inhibiting tumor cell proliferation, inducing apoptosis, and playing an anti-angiogenic role, have been approved by the FDA and CFDA as first-line treatment for patients with advanced liver cancer. lenvatinib showed longer disease progression than sorafenib (8.9 months vs.
- Phase 1: an early, usually small safety study
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
- Age ≥18 years old, ≤75 years old, gender unlimited;
- primary hepatocellular carcinoma proved pathologically and clinically;
- 2 months after radical resection or ablation, imaging examination (MRI, CT plain enhanced) showed no tumor lesions, HCC recurred within 3 years after...
- ECOG score 0-1;
- Recurrent liver cancer meets the Milan criteria: single tumor diameter ≤5cm or multiple tumors less than 3 with a maximum diameter ≤3cm, no major...
You likely can't join if
- (1) previous radiotherapy, hormone therapy or molecular targeted therapy; (2) Patients with distant metastasis confirmed by imaging; (3) The subject...
See the full eligibility criteria
- Age ≥18 years old, ≤75 years old, gender unlimited;
- primary hepatocellular carcinoma proved pathologically and clinically;
- 2 months after radical resection or ablation, imaging examination (MRI, CT plain enhanced) showed no tumor lesions, HCC recurred within 3 years after surgery, no extrahepatic metastasis;
- ECOG score 0-1;
- Recurrent liver cancer meets the Milan criteria: single tumor diameter ≤5cm or multiple tumors less than 3 with a maximum diameter ≤3cm, no major vascular invasion, no lymph node metastasis or extrahepatic metastasis;
- Child-Pugh liver function grades: A, B;
- Expected survival \> 6 months;
- Adequate organ function: ① no need for growth factors and blood components within 2 weeks prior to enrollment; (2) Cardiac function: no heart disease, coronary heart disease, cardiac function level 1-2; ③ In the first 7...
- Patients with normal blood pressure or hypertension should use antihypertensive drugs to control blood pressure within the normal range;
- Diabetic patients should control fasting blood glucose ≤8mmol/L by hypoglycemic drugs;
- No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation, etc.) that conflict with the Plan;
- No history of other malignant tumors;
- Women of childbearing age must have a negative blood pregnancy test within seven days, and people of childbearing age must use appropriate contraception during the test and for six months after the test;
- The patient agrees to participate in the clinical study and sign the Informed Consent.
- (1) previous radiotherapy, hormone therapy or molecular targeted therapy; (2) Patients with distant metastasis confirmed by imaging; (3) The subject has had or co-has other malignancies (other than cured basal cell...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.