Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and/or Bevacizumab Therapy as First Line for Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Cytohistological confirmation is required for diagnosis of cancer.

• Signed informed consent before recruiting.

• Age above 18 years with estimated survival over 3 months.

• Child-Pugh class A or B/Child score \> 7; ECOG score \< 2

• Tolerable coagulation function or reversible coagulation disorders

• Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L; PLT ≥50×10E9/L;INR \< 2.3 or PT \< 6 seconds above control;Cr ≤ 145.5 umul/L;Albumin \> 28 g/L;Total bilirubin \< 51 μmol/L

• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.

• Birth control.

• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Locations
Other Locations
China
Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhenfeng Zhang, MD, PhD
zhangzhf@gzhmu.edu.cn
+862039195966
Backup
Bingjia He, MD
464677938@qq.com
+862039195965
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2035-12-30
Participants
Target number of participants: 90
Treatments
Experimental: IT injection of double ICI
Arm 1: intra-tumor injection of double ICIs only.
Experimental: IT injection of double ICI and chemodrug
Arm 2: intra-tumor injection of double ICIs and a chemodrug.
Experimental: IT injection of double ICI and chemodrug plus bevacizumab
Arm 3: intra-tumor injection of double ICIs, a chemodrug, and bevacizumab.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov