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Trial Title:
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
NCT ID:
NCT05864105
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
PD-L1/VEGF
FOLFOX-4
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
PM8002
Description:
PM8002 20mg/kg Q2W
Arm group label:
PM8002+FOLFOX-4
Intervention type:
Drug
Intervention name:
FOLFOX regimen
Description:
day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion],
followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day
2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2,
intravenous bolus; 600 mg/m2, 22-h infusion]
Arm group label:
PM8002+FOLFOX-4
Summary:
This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and
safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects
with inoperable HCC.
Detailed description:
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation in clinical study; fully understand the study and sign
informed consent voluntarily; willing to follow and able to complete all test
procedures;
2. Male or female aged >= 18 years;
3. HCC diagnosed by pathology or clinical;
4. BCLC stage C or B (unresectable or/and not suitable for local therapy);
5. Child-Pugh score <= 7;
6. ECOG performance status of 0 or 1.
Exclusion Criteria:
1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed
cholangiocarcinoma and HCC;
2. Symptomatic CNS metastases, not suitable for the study assessed by investigator;
3. Evidence of major coagulopathy or other obvious risk of bleeding;
4. Unable to accept enhanced imaging examination (CT or MRI) for any reason;
5. History of severe allergic disease, severe allergy to drugs or known allergy to any
component of the drug in this study;
6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;
8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
9. Patients with psychiatric disorders or poor compliance;
10. Women who are pregnant or breastfeeding;
11. The condition of the subject, as determined by the investigator, may increase the
risk of after study treatment, or may cause confusion about the interpretation of
the toxic reaction and AE;
12. Other conditions lead to inappropriate to participate in this study as judged by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of The University of Chinese Academy of Sciences
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangdong Cheng
Phone:
+86 571 88888888
Email:
Chengxd516@126.com
Start date:
April 22, 2022
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05864105
