Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma

NCT05970666 | Recruiting Phase 2

• 1 other identifier: 23-OBU-FJ-HCC-II-012
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma

Conditions

Adebrelimab; Hepatocellular Carcinoma; Transformation; Bevacizumab; TACE

Outcome Measures

Primary Outcomes (2)

• Objective response rate（ORR）

  Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.

  Up to 2 years

• Occurence of AE and SAE

  Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

  Up to 2 years

Secondary Outcomes (8)

• Radical (R0) resection rate after conversion therapy

  Up to 2 years

• percent conversion

  Up to 2 years

• Pathological complete response rate (pCR)

  Up to 2 years

• Major pathological response rate (MPR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: TACE with adebrelimab and bevacizumab

Interventions

TACE with adebrelimab and bevacizumab DRUG

TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 \~ 75, both male and female；
• Strictly comply with the primary liver cancer diagnosis and treatment standard (2022 edition) clinical diagnosis criteria or primary hepatocellular carcinoma diagnosed by pathological histology or cytology examination, and at least one measurable lesions (according to the RECIST1.1 standard, the spiral CT scan of 10mm or short diameter of 15mm）；
• Patients without previous systematic treatment and inoperable resection / radical ablation surgery, but who can tolerate TACE;
• The CNLC stage is Ⅱa-Ⅲb stage;
• The Child-Pugh grade of liver function is A grade or B grade (5-7 points);
• The ECOG PS score is 0-1 points;
• Expected survival period of 12 weeks;
• If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be \<2000 IU / mL (if the study site has only copy / mL testing units, Must be \<12500 copy / mL), And received at least 14 days before initiating anti-HBV treatment (according to local standard therapy, e. g. entecavir) and willing to receive antiviral treatment throughout the study; hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral treatment according to local standard treatment guidelines and liver function within grade CTCAE 1 elevation;
• Main organs function are normal and meet the following criteria: (1) The blood routine examination standards should be met with: (no blood transfusion within 14 days) A. Hemoglobin (HB), 90g / L, B. White blood cell count (WBC) 3109 / L C. Absolute neutrophil count (ANC) 1.5109 / L, D. Platelet (PLT) 80109 / L;(2) Biochemical examination shall meet the following standards: A. Bilirubin (BIL) \<1.5 times the upper limit of normal value (ULN); B. Glutamic gamma aminotransferase (ALT) and glutamate aminotransferase AST \<5 ULN; C. Serum creatinine (Cr)≤1.5ULN；
• Women of childbearing age must have negative pregnancy test (serum) or urine HCG within 7 days before enrollment and are willing to use appropriate contraception during treatment and 24 weeks after the last administration of test drug; for men, surgical sterilization or agree to use appropriate contraception during and 24 weeks after the last administration of trial drug;
• The subjects volunteered to join the study and had good compliance with the follow-up.

You may not qualify if:

• Pregnant or lactating women;
• The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;
• Diffuse liver cancer;
• Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except for cured basal skin cell carcinoma and cervix carcinoma in situ);
• Patients with consciousness disorders or unable to cooperate with the treatment, combined with patients with mental illness;
• Patients who have participated in other clinical trials in the recent three months;
• Previous history of other malignancies or have received targeted therapy and other PD-1 / PD-L1 inhibitor therapy;
• Received major surgery or chemotherapy or other systemic therapy for target lesions (including not limited to radiation therapy, ablation therapy, etc.) within 1 month prior to enrollment;
• Use of immunosuppressants or systemic hormone therapy within 14 days before enrollment to achieve immunosuppressive purposes (dose\> 10mg / day prednisone or other efficacy hormones);
• Liver function was graded as Child-Pugh C, which could not be improved by liver care treatment；
• esophageal (gastric fundus) varices rupture and bleeding within 1 month before treatment；
• Uncorrectable coagulopathy and severe blood abnormalities, with severe bleeding tendency. Platelet count \<50109 / L and severe coagulation abnormalities against surgery (anticoagulation therapy and / or anticoagulant therapy should be stopped for more than 1 week before radiation therapy);
• A stubborn amount of ascites, pleural fluid, malignant fluid;
• Active infection, especially the inflammation of the biliary tract system;
• Severe functional failure of the liver, kidney, heart, lung, brain and other major organs;

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jianbo Chen

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Feng Ye

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• congren Wang

  Quanzhou First Hospital

  STUDY DIRECTOR

• Qinghe Cai

  Affiliated Hospital of Putian University

  STUDY DIRECTOR

• Jiafei Chen

  Putian First Hospital

  STUDY DIRECTOR

• Yongzhong Wang

  Sanming Second Hospital

  STUDY DIRECTOR

• Feng Lin

  Ningde Mindong Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianbo Chen

CONTACT

15605921022; 274439002@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 1, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)