Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Resectable Hepatocellular Carcinoma
Macrovascular Invasion
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
At the time of diagnosis, the majority of hepatocellular carcinoma (HCC) patients are at the intermediate to advanced stages, with a 50-70% incidence of macrovascular invasion (including portal vein, ...
Eligibility Criteria
Inclusion
- All patients must be pathologically confirmed to have hepatocellular carcinoma by biopsy；
- No previous antitumor treatment;
- Tumor number ≤ 3, diameter ≤ 10 cm, confined to one lobe of the liver or the middle lobe, evaluated by a surgeon as resectable;
- Combined with vascular invasion, with the following extents: unilateral portal vein invasion without extending beyond the main portal vein; hepatic vein invasion not reaching the inferior vena cava; unilateral bile duct invasion not reaching the common hepatic duct;
- No extra-hepatic metastasis or lymph node metastasis.
- Normal liver volume ≥ 700 cc;
- Patient KPS ≥ 90;
- Liver function Child-Pugh class A;
- Estimated survival of more than 6 months;
- Function of important organs meets the following requirements: white blood cells ≥ 4.0×10\^9/l, neutrophils ≥ 1.5×10\^9/l, platelets ≥ 80.0×10\^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5× ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min; no severe organic diseases;
- The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication and postoperative follow-up requirements as designed in this study.
Exclusion
- Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment;
- Diffuse type of HCC, or tumor volume exceeding 50% of liver volume;
- Portal vein invasion extending beyond the main tract of the portal vein, or hepatic vein invasion reaching the inferior vena cava, or bile duct invasion extending beyond the common hepatic duct;
- Contraindications to surgical resection, SBRT and immunotherapy;
- History of other malignant tumors;
- Combined with immunological diseases or other conditions requiring long-term steroid treatment;
- Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
- History of organ transplantation;
- Pregnant or breastfeeding women;
- Other factors that may affect patient enrollment and assessment outcomes;
- Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06524466
Start Date
July 23 2024
End Date
December 1 2026
Last Update
July 29 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060