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Trial · Interventional

Status unknownPhase 4Registry data

"cindilizumab + Bevacizumab + Coenzyme I for Injection" in Unresectable Hepatocellular Carcinoma

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
37 participants (estimated)
Sponsor
Anhui Provincial Hospital · Other gov
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
19 Dec 2023
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
First posted
19 Sept 2024
Last update posted
19 Sept 2024
Conditions
Unresectable Hepatocellular Carcinoma

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 4

    "cindilizumab + Bevacizumab + Coenzyme I for Injection" in Unresectable Hepatocellular Carcinoma

    NCT06590844

    19 Dec 2023 to est. Mar 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 radical surgical resection or local treatment, or have disease progression after surgical resection or local treatment, the efficacy and safety of "cindilizumab + bevacizumab + coenzyme I for injection" are initially explored.

Interventions

  • Injectable coenzyme IDrug

Arms1

  • Experimental

    experimental group

    On the first day, we will treat patients with Tybo Sulsintilimab ® 200mg IV and Dalutin ® Bevacizumab 15mg/kg IV every 21 days. The first to third days were treated with injectable coenzyme I, 100mg/day IV, every 21 days as a cycle.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. ORR

    Time frame · 4-6 weeks

    Registry description

    ORR as assessed by mRECIST 1.1

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Days up to 80 Days
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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. 2. 18 years old≤ age ≤ 80 years old 3. ECOG PS 0-1 points, Child-Pugh score ≤7 points. 4. 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. 5. 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. 6. Have adequate organ and bone marrow function. The laboratory test values within 7 days prior to enrollment meet the following requirements: 1. 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. 2. 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. 3. 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. 4. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 7. 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 Criteria: 1. Previously confirmed fibrolamellarhepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology. 2. Have a history of hepatic encephalopathy, or have a history of liver transplantation. 3. 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.. 4. Pleural effusion, ascites, and pericardial effusion that need to be drained with clinical symptoms. 5. Hepatitis B surface antigen (HbsAg) is positive at the same time as anti-HCV antibodies. 6. There are central nervous system metastases. 7. HIV infection. 8. Gastroscopy showed positive red sign of esophageal and gastric varices. 9. Women who are pregnant or preparing to become pregnant or breastfeeding. 10. Those who are known to be allergic to coenzyme I and its components or have serious adverse reactions. 11. Those who have participated in other clinical trials within 3 months before participating in this trial. 12. 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. 13. Participating in other interventional clinical trials.

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