Irradiation Stent Placement Plus TACE for HCC and PVTT

• Status: Unknown status
• Trial end date: 2021-11-10
• Target enrollment: 0
• Participant gender: All

Summary

The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongda Hospital
• Treatments: Sorafenib

Criteria

Inclusion Criteria:

• •

1. Histologically-confirmed or clinical diagnosis of hepatocellular carcinoma (HCC)

2. Histologically-confirmed or imaging-based diagnosis malignant portal vein tumor thrombosis(PVTT)

3. Portal trunk invaded tumor thrombosis without the infiltration of superior mesenteric vein or inferior caval vein

4. At least one patent first branch of the portal vein

5. Measurable intrahepatic disease according to mRECIST

6. Child-Pugh class A or B

7. Eighteen years of age or older

8. With an expected lifespan more than 3 months

9. ECOG performance status 0, 1 or 2

10. Required baseline laboratory data within the following parameters:

1. Neutrophils ≥ 1.0×10⁹/L 2. Platelets ≥ 50×10⁹ /L 3. Hemoglobin ≥ 90 g/L 4. Serum aspartate aminotransferase (AST; ALT≤5 x ULN) 5. Serum creatinine ≤1.5 x ULN 6. INR <1.7 or prothrombin time (PT) < 4 seconds above ULN 7. Total bilirubin < 34.2 umol/L(2 mg/dL) 11. Signed and dated informed consent and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Presence of distant metastasis outside liver or diagnosis of any second malignancy beyond HCC

2. Less than 30% volume of uninvolved liver

3. Prior systemic treatment, including prior treatment with sorafenib or any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cry ablation)

4. Presence of clinically relevant ascites (that can be classified as Child-Pugh score of 3).

5. Documented variceal hemorrhage within 6 months of study entry or presence of esophageal varices at risk of bleeding (as documented by endoscopy/CT/fluoroscopy)

6. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry

7. Any of the following within the 3 months prior to study drug administration:

severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.

8. Ongoing cardiac dysrhythmias of NCI CTCAE grade≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females.

9. Hypertension that cannot be controlled by medications (blood pressure >150/100 mm Hg despite optimal medical therapy).

10. Concomitant treatment with botanical formulation having an approved indication for cancer treatment, such as "Xiao Chai Hu Tang", "Kanglaite", "Huai Er Ke Li"etc.

11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

12. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to study enrollment.

13. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.