Unresectable Hepatocellular CarcinomaPhase 2NCT06360042
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
A Phase 2 study testing Adebrelimab plus Apatinib, Adebrelimab plus Bevacizumab and Camrelizumab plus Apatinib in people with Unresectable Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Adebrelimab plus Apatinib, Adebrelimab plus Bevacizumab and Camrelizumab plus Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
- No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
- BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
- At least one measurable lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Child-Pugh class of A5 to B7
- Adequate organ function
Who cannot join
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- Moderate-to-severe ascites with clinical symptoms
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Known genetic or acquired hemorrhage or thrombotic tendency
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
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- Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
- History of hepatic encephalopathy
- Previous or current presence of metastasis to central nervous system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Zhou, 13366152815, Joelbmu@126.com
About this study
Official title: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Adebrelimab plus Apatinib, Adebrelimab plus Bevacizumab, Camrelizumab plus Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab plus ApatinibDrug
Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
Adebrelimab plus BevacizumabDrug
Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
Camrelizumab plus ApatinibDrug
camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd) Receives: Drug: Adebrelimab plus Apatinib |
| 2 | Experimental | Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w) Receives: Drug: Adebrelimab plus Bevacizumab |
| 3 | Experimental | Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd) Receives: Drug: Camrelizumab plus Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month overall survival rate
Measured: Up to approximately 3 years
Secondary outcomes (8)
ORR
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
DCR
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
DoR
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
TTR
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
TTP
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
PFS
Assessed by the investigator per RECIST v1.1 criteria
Measured: Up to approximately 3 years
OS
Measured: Up to approximately 3 years
safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Zhou, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360042
- Sponsor's protocol ID
- MA-HCC-II-021
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT06360042
- Acronym / sponsor ID
- MA-HCC-II-021
- Conditions
- Unresectable Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Apr 2024 (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, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Adebrelimab plus ApatinibAdebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd) |
| 2 | Experimental | Drug: Adebrelimab plus BevacizumabAdebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w) |
| 3 | Experimental | Drug: Camrelizumab plus ApatinibCamrelizumab (200mg iv q2w) plus Apatinib(250mg po qd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
- No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
- BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
- At least one measurable lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1
Key exclusion criteria (9 listed)
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- Moderate-to-severe ascites with clinical symptoms
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Known genetic or acquired hemorrhage or thrombotic tendency
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 |
|---|---|---|
| Adebrelimab plus ApatinibAdebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily | Drug | 1 |
| Adebrelimab plus BevacizumabAdebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks | Drug | 2 |
| Camrelizumab plus Apatinibcamrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily | Drug | 3 |
Primary outcome
12-month overall survival rate
Time frame: Up to approximately 3 years
8 secondary outcomes
ORR
Time frame: Up to approximately 3 years
DCR
Time frame: Up to approximately 3 years
DoR
Time frame: Up to approximately 3 years
TTR
Time frame: Up to approximately 3 years
TTP
Time frame: Up to approximately 3 years
PFS
Time frame: Up to approximately 3 years
OS
Time frame: Up to approximately 3 years
safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jun Zhou principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab plus Apatinib, Adebrelimab plus Bevacizumab and Camrelizumab plus Apatinib in people with Unresectable Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhou (13366152815, Joelbmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month overall survival rate (time frame: Up to approximately 3 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 22 Apr 2024.