NCT05864105CompletedPhase 2
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 9 May 2023
- Start date
- 22 Apr 2022
- Primary completion date
- 24 Jul 2025
- Lead sponsor
- Biotheus Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05864105
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- From 22 Apr 2022 to the primary completion date, 24 Jul 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of major coagulopathy or other obvious risk of bleeding;
- History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- Patients with psychiatric disorders or poor compliance;
- 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;
- Other conditions lead to inappropriate to participate in this study as judged by the investigator.
Other
- Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- Symptomatic CNS metastases, not suitable for the study assessed by investigator;
- Unable to accept enhanced imaging examination (CT or MRI) for any reason;
- Women who are pregnant or breastfeeding;
Who the study is looking for
- Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- Male or female aged \>= 18 years;
- HCC diagnosed by pathology or clinical;
- BCLC stage C or B (unresectable or/and not suitable for local therapy);
- Child-Pugh score \<= 7;
- ECOG performance status of 0 or 1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Cancer Hospital of The University of Chinese Academy of Sciences Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinhua Municipal Centeral Hospital Medical Group Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.