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New treatment option for Hepatoblastoma
Official title Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children
ClinicalTrials.gov ID: NCT07188311
What this study is testing
What is Pucotenlimab ,Lenvatinib?
Pucotenlimab ,Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hepatoblastoma.
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-cohort study. Pediatric patients with advanced, relapsed/refractory hepatoblastoma who have previously failed first-line or higher systemic therapy will receive 2 cycles of treatment with sintilimab combined with lenvatinib and chemotherapy (irinotecan).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Voluntarily enroll in the study and sign a written informed consent form; Aged 2-18 years, with no gender restrictions; Patients with histologically...
- Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L;
- Platelet count ≥100×10⁹/L; Blood biochemistry test:
- Total bilirubin ≤1.5×Upper Limit of Normal (ULN);
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5×ULN (for participants with liver metastases, ALT or AST ≤5×ULN is allowed);
You likely can't join if
- Received chemotherapy within 21 days before the first dose of study drug; received anti-cancer treatment other than chemotherapy or study drug...
- Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
- Active tuberculosis;
- Other uncontrolled active infections (CTCAE V5.0 \>Grade 2); Failure to recover from surgery, such as unhealed incisions or severe postoperative...
See the full eligibility criteria
- Voluntarily enroll in the study and sign a written informed consent form; Aged 2-18 years, with no gender restrictions; Patients with histologically or cytologically confirmed locally advanced or metastatic...
- Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L;
- Platelet count ≥100×10⁹/L; Blood biochemistry test:
- Total bilirubin ≤1.5×Upper Limit of Normal (ULN);
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5×ULN (for participants with liver metastases, ALT or AST ≤5×ULN is allowed);
- Creatinine ≤1.5×ULN; Coagulation function:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN;
- Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
- Myocardial enzyme profile within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed for enrollment).
- Received chemotherapy within 21 days before the first dose of study drug; received anti-cancer treatment other than chemotherapy or study drug treatment within 28 days (or 5 times the half-life, whichever is shorter)...
- Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
- Active tuberculosis;
- Other uncontrolled active infections (CTCAE V5.0 \>Grade 2); Failure to recover from surgery, such as unhealed incisions or severe postoperative complications; Vaccination with any live-attenuated vaccine within 4 weeks...
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, Guangzhou, 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, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, Guangzhou, 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.