PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

Trial status:Study Complete
Trial ID:
PM8002 -B006C-HCC-R
NCT ID:
NCT05864105
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
N/A
Study Complete

Trial Details

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.

Medical Condition
Unmapped
Study Drug
PM8002
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FOLFOX regimen
Phase
Phase 2
Type
Interventional
Estimated Enrolment
35
Estimated Trial Date
Apr 2022 - Jul 2025

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion 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.

Trial Locations

Location
Status
Location
Anhui Provincial Hospital
Hefei, Anhui, China
Status
Location
Fujian Cancer Hospital
Fuzhou, Fujian, China
Status
Location
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Status
Location
Henan Cancer Hospital
Zhengzhou, Henan, China
Status
Location
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Status
Location
The First Hospital of Jilin University
Changchun, Jilin, China
Status
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