Hepatocellular CarcinomaPhase 2NCT05864105
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
A Phase 2 study testing PM8002 and FOLFOX regimen in people with Hepatocellular Carcinoma, run by Biotheus Inc. at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- PM8002 and FOLFOX regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 9 sitesChina
- Study dates
- 22 Apr 2022to 24 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- Symptomatic CNS metastases, not suitable for the study assessed by investigator;
- Evidence of major coagulopathy or other obvious risk of bleeding;
- Unable to accept enhanced imaging examination (CT or MRI) for any reason;
- 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;
Show all 12Show fewer
- 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;
- Women who are pregnant or breastfeeding;
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
The First Hospital of Jilin University
Changchun, Jilin
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Fujian Cancer Hospital
Fuzhou, Fujian
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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.
Read the detailed description
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PM8002, FOLFOX regimen
- Keywords
- PD-L1/VEGF, FOLFOX-4
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Biological
PM8002 20mg/kg Q2W
FOLFOX regimenDrug
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]
| Study group | Role | What they receive |
|---|---|---|
| PM8002+FOLFOX-4 | Experimental | PM8002 20mg/kg Q2W 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] Receives: Biological: PM8002; Drug: FOLFOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start22 Apr 2022
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Biotheus Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieer Ying, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864105
- Sponsor's protocol ID
- PM8002 -B006C-HCC-R
- Status last verified
- Jul 2025
- First submitted
- 9 May 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05864105
- Acronym / sponsor ID
- PM8002 -B006C-HCC-R
- Conditions
- Hepatocellular Carcinoma
- Keywords
- PD-L1/VEGF, FOLFOX-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM8002+FOLFOX-4 | Experimental | Biological: PM8002, Drug: FOLFOX regimenPM8002 20mg/kg Q2W 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] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- Symptomatic CNS metastases, not suitable for the study assessed by investigator;
- Evidence of major coagulopathy or other obvious risk of bleeding;
- Unable to accept enhanced imaging examination (CT or MRI) for any reason;
- History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM8002PM8002 20mg/kg Q2W | Biological | PM8002+FOLFOX-4 |
| FOLFOX regimenday 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] | Drug | PM8002+FOLFOX-4 |
Primary outcome
Objective Response Rate
Time frame: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
Related trials for Hepatocellular Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 2
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Combined Hepatocellular and Cholangiocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieer Ying principal investigator
Zhejiang Cancer Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PM8002 and FOLFOX regimen in people with Hepatocellular Carcinoma, run by Biotheus Inc. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.