Clinical trial NCT05864105: PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
Official title: A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: PD-L1/VEGF
FOLFOX-4
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Centeral Hospital Medical Group
state: Zhejiang
Study officials:
affiliation: Cancer Hospital of The University of Chinese Academy of Sciences
name: Jieer Ying
role: PRINCIPAL_INVESTIGATOR
References: