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

NCT06590844 | Active Not Recruiting Phase 4

• 1 other identifier: KNPD1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR as assessed by mRECIST 1.1

  4-6 weeks

Study Arms (1)

experimental group

EXPERIMENTAL

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.

Drug: Injectable coenzyme I

Interventions

Injectable coenzyme I DRUG

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.

experimental group

Eligibility Criteria

• Age: 18 Days - 80 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

AnhuiI Provincial Hospital

Hefei, Anhui, 230000, China

Location

Study Officials

• Liangxin Liu, Professor

  AnhuiI Provincial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)