Status:
ACTIVE_NOT_RECRUITING
"cindilizumab + Bevacizumab + Coenzyme I for Injection" in Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study is a single-arm, single-center, non-randomized, open-label study. A total of 37 patients with locally advanced or metastatic HCC who have not received systemic therapy, are not suitable for...
Detailed Description
1\. Background According to the latest global cancer burden data for 2020 released by the World Health Organization Agency for International Research on Cancer (IARC), about 390,000 people die from li...
Eligibility Criteria
Inclusion
- Histological/cytologically confirmed hepatocellular carcinoma, or cirrhosis of the liver meets the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for hepatocellular carcinoma.
- 18 years old≤ age ≤ 80 years old
- ECOG PS 0-1 points, Child-Pugh score ≤7 points.
- The 2022 edition of the Guidelines for the Diagnosis and Treatment of Liver Cancer of the National Health Commission of China is stage IIb and above.
- Have not received systemic anti-tumor therapy for HCC before the first dose (enrollment is allowed more than 6 months after the end of postoperative adjuvant chemotherapy), and enrollment is allowed 28 days after the end of TACE treatment.
- Have adequate organ and bone marrow function. The laboratory test values within 7 days prior to enrollment meet the following requirements:
- Routine blood count: absolute neutrophil count (ANC) ≥1.5× 109/L; Platelet count (PLT) ≥ 75×10 9/L; Hemoglobin content (HGB) ≥ 9.0 g/dL.
- Liver function: serum total bilirubin (TBIL) ≤2× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; serum albumin≥ 28 g/L; Alkaline phosphatase (ALP) ≤5×ULN.
- Renal function: serum creatinine (Cr) ≤ 1.5× ULN or creatinine clearance (CCr) ≥ 50mL/min; Patients with a urine protein ≥ 2+ should have a 24-hour urine collection and a 24-hour urine protein quantification \<1 g.
- Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- Patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA less than 2000IU/ml or 10 copies/ml; Hepatitis C virus (HCV) RNA is less than 1000 copies/ml.
- Agree to participate in this clinical trial and sign a written informed consent form..
Exclusion
- Previously confirmed fibrolamellarhepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology.
- Have a history of hepatic encephalopathy, or have a history of liver transplantation.
- The portal vein trunk cancer thrombus involves the contralateral portal vein branch at the same time, or the superior mesenteric vein and inferior vena cava cancer thrombus at the same time..
- Pleural effusion, ascites, and pericardial effusion that need to be drained with clinical symptoms.
- Hepatitis B surface antigen (HbsAg) is positive at the same time as anti-HCV antibodies.
- There are central nervous system metastases.
- HIV infection.
- Gastroscopy showed positive red sign of esophageal and gastric varices.
- Women who are pregnant or preparing to become pregnant or breastfeeding.
- Those who are known to be allergic to coenzyme I and its components or have serious adverse reactions.
- Those who have participated in other clinical trials within 3 months before participating in this trial.
- In the judgment of the investigator, the patient is unable to complete this study or is unable to comply with the requirements of this study.
- Participating in other interventional clinical trials.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06590844
Start Date
December 19 2023
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AnhuiI Provincial Hospital
Hefei, Anhui, China, 230000