Hepatocellular CarcinomaPhase 2HZ-T-PD1-APANCT03793725
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
A Phase 2 study testing SHR1210 and Apatinib in people with Hepatocellular Carcinoma, run by Yanqiao Zhang.
Trial summary
This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SHR1210 and 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2019to 30 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign informed consent .
- Men or women aged 18-75 years
- patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
- The patients can swallow pills normally.
- ECOG score was 0 or 1.
- Have a life expectancy of at least 12 weeks.
- The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
Who cannot join
- Subjects had any active autoimmune disease or history of autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- A heart condition or disease that is not well controlled.
- Subjects had active infections.
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- Other clinical trials of drugs were used within 4 weeks prior to the first administration.
- The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
- There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma
This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.
This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SHR1210, Apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1210Drug
Anti-PD-1 Antibody
ApatinibDrug
Anti-angiogenic drugs
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 + Apatinib | Experimental | Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd Receives: Drug: SHR1210; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 (resection rate)
R0 resection rate
Measured: 1 week after surgery
Secondary outcomes (2)
ORR
Objective Response Rate
Measured: from the first drug administration up to one year
RFS
relapse free survival
Measured: from the first drug administration up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start30 Jan 2019 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2021 (estimated)
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqiao Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor-investigator, Yanqiao Zhang, Harbin Medical University
- Investigators
- Zhang Yanqiao, PHD, Principal investigator, Study Principal Investigator Harbin Medical University Cancer Hosptital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793725
- Sponsor's protocol ID
- HZ-T-PD1-APA
- Acronym
- HZ-T-PD1-APA
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 4 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03793725
- Acronym / sponsor ID
- HZ-T-PD1-APA / HZ-T-PD1-APA
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yanqiao ZhangUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 30 Jan 2019 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 4 Jan 2019 (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 Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.
This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 + Apatinib | Experimental | Drug: SHR1210, Drug: ApatinibDrug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in this study and sign informed consent .
- Men or women aged 18-75 years
- patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
- The patients can swallow pills normally.
- ECOG score was 0 or 1.
Key exclusion criteria (9 listed)
- Subjects had any active autoimmune disease or history of autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- A heart condition or disease that is not well controlled.
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 |
|---|---|---|
| SHR1210Anti-PD-1 Antibody | Drug | SHR-1210 + Apatinib |
| ApatinibAnti-angiogenic drugs | Drug | SHR-1210 + Apatinib |
Primary outcome
R0 (resection rate)
Time frame: 1 week after surgery
R0 resection rate
2 secondary outcomes
ORR
Time frame: from the first drug administration up to one year
RFS
Time frame: from the first drug administration up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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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. This study is not recruiting at the moment.
Zhang Yanqiao, PHD principal investigator
Study Principal Investigator Harbin Medical University Cancer Hosptital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR1210 and Apatinib in people with Hepatocellular Carcinoma, run by Yanqiao Zhang.
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 8 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: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yanqiao, PHD (138 4512 0210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 (resection rate) (time frame: 1 week after surgery). 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 4 Jan 2019.