Hepatocellular CarcinomaPhase 2NCT03857815
Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Hepatocellular Carcinoma
A Phase 2 study testing anti-PD-1 antibody in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in 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?
- anti-PD-1 antibody
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to 28 Feb 2022
- 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
- Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics.
- Patients including metastasis are inoperable or unresectable. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies. Lesions should be no more than five and be able to administrate SBRT, and at least one lesion is evaluable.
- The Laboratory test results must meet the following criteria:
- neutrophils ≥1.5×109/L
- Platelets ≥75×109/L
- Hemoglobin ≥90g/L (no blood transfusion within past 14 days)
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- Serum Cr ≤1.5×ULN, endogenous creatinine clearance rate >60ml/min (Cockcroft-Gault formula)
- AST ≤2.5×ULN, ALT ≤2.5×ULN; both ALT and AST ≤5×ULN if there are liver metastasis
- TSH, FT3, FT4 are within ± 10% of the normal range
- blood coagulation functon: INR ≤2.5×ULN and APTT ≤ 1.5 ULN
- ECOG performance status: 0-1.
- Life expectancy ≥6 months.
- No history of abdominal irradiation.
- aged 18 to 75 years old are eligible.
- Patients must be able to understand and willing to sign a written informed consent document.
- Female patients within childbearing age or male patients whose sexual partners are women within childbearing age need to take effective contraceptive measures throughout the treatment period and 6 months after the treatment.
Who cannot join
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma.
- History of hepatic encephalopathy or liver transplantation
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included.
- Untreated hepatitis infection: HBV DNA>2000IU/mlor104 copy/ml, HCV RNA> 103copy/ml, both HbsAg and anti-HCV body are positive.
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
- In the past six months, there was a history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
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- History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
- Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated.
- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- Severe infections are in active stage or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia.
- Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors
- Immunosuppressive drugs have been used in the past four weeks, excluding local glucocorticoids or systemic glucocorticoids (i.e. no more than 10 mg/day prednisone or other glucocorticoids of equivalent dosage) through nasal spray, inhalation or other routes, and temporary use of glucocorticoids for the treatment of dyspnea symptoms of asthma, chronic obstructive pulmonary disease.
- Inoculation of any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within past 4 weeks;
- Received systemic immunostimulant therapy in the past four weeks
- Large surgical (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been performed in the past four weeks.
- Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary tumors may lead to higher medical risks and/or uncertainty in survival assessment.
- Some acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the result: increased risk of participating in the study or drug administration, or interfering with the interpretation of research results, and according to the judgement of the researchers, patients are classified as not eligible to participate in the study.
- Other malignant tumors were diagnosed within 5 years before the first administration, excluding cured cutaneous basal cell carcinoma, cured squamous cell carcinoma and/or cured cancer in situ. If other malignant tumors or hepatocellular carcinomas are diagnosed more than five years before administration, pathological or cytological diagnosis should be taken from recurrent and metastasis sites.
- Any prior immune checkpoint inhibition treatment with anti-PD-1/PD-L1 /PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on the T cell co-stimulus or checkpoint pathway)
- Patients with known sensitivity or allergy to any components of humanized anti-PD-1 antibody.
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Yixing Chen, Phd, 86-64041990-2764, chen.yixing@zs-hospital.sh.cn
Zhaochong Zeng, Professor
About this study
Official title: A Phase II Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anti-PD-1 Antibody （IBI308） in Patients With Hepatocellular Carcinoma
The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.
Read the detailed description
Stereotactic Body Radiation Therapy (SBRT) is an acceptable option for HCC patients not amenable to surgery or transplantation or manifested with oligometastasis. Recent studies have shown that SBRT plus immune checkpoint inhibitors may potentiate the effect of RT on tumor cell killing. The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- anti-PD-1 antibody
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-PD-1 antibodyRadiation
In patients with inoperable hepatocellular carcinoma or recurrence after local or regional therapy, stereotactic body radiation therapy will be combined with anti-PD-1 antibody.
Stereotactic body radiation therapy: SBRT is delivered to 1~5 Evaluable lesions of liver, lung, bone, brain or lymph nodes in limited fractions .
Anti-PD-1 treatment: anti-PD-1 antibody (IBI308) is injected intravenously 200mg every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| SBRT in combined with anti-PD-1 antibody | Experimental | HCC Patients will be received stereotactic body radiation therapy (SBRT) to primary lesions or metastatic lesions, such as liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment. Receives: Radiation: anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 2 years
Secondary outcomes (4)
Adverse Events
Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE).
Measured: 2 years
OS
Overall survival
Measured: 2 years
DCR
disease control rate
Measured: 2 years
ORR
Objective Response Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start25 Mar 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion28 Feb 2022 (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.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao-Chong Zeng, PhD, Principal investigator, Fudan UniversityTian-shu Liu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857815
- Sponsor's protocol ID
- ZS-HCC-SBRTPD1
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anti-PD-1 Antibody （IBI308） in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03857815
- Acronym / sponsor ID
- ZS-HCC-SBRTPD1
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 25 Mar 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 28 Feb 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.
The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.
Detailed description
Stereotactic Body Radiation Therapy (SBRT) is an acceptable option for HCC patients not amenable to surgery or transplantation or manifested with oligometastasis. Recent studies have shown that SBRT plus immune checkpoint inhibitors may potentiate the effect of RT on tumor cell killing. The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT in combined with anti-PD-1 antibody | Experimental | Radiation: anti-PD-1 antibodyHCC Patients will be received stereotactic body radiation therapy (SBRT) to primary lesions or metastatic lesions, such as liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics.
- Patients including metastasis are inoperable or unresectable. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies. Lesions should be no more than five and be able to administrate SBRT, and at least one lesion is evaluable.
- The Laboratory test results must meet the following criteria:
- ECOG performance status: 0-1.
- Life expectancy ≥6 months.
Key exclusion criteria (21 listed)
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma.
- History of hepatic encephalopathy or liver transplantation
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included.
- Untreated hepatitis infection: HBV DNA>2000IU/mlor104 copy/ml, HCV RNA> 103copy/ml, both HbsAg and anti-HCV body are positive.
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
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 |
|---|---|---|
| anti-PD-1 antibodyIn patients with inoperable hepatocellular carcinoma or recurrence after local or regional therapy, stereotactic body radiation therapy will be combined with anti-PD-1 antibody. Stereotactic body radiation therapy: SBRT is delivered to 1~5 Evaluable lesions of liver, lung, bone, brain or lymph nodes in limited fractions . Anti-PD-1 treatment: anti-PD-1 antibody (IBI308) is injected intravenously 200mg every three weeks. | Radiation | SBRT in combined with anti-PD-1 antibody |
Primary outcome
PFS
Time frame: 2 years
Progression Free Survival
4 secondary outcomes
Adverse Events
Time frame: 2 years
OS
Time frame: 2 years
DCR
Time frame: 2 years
ORR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Zhao-Chong Zeng, PhD principal investigator
Fudan University
Tian-shu Liu, PhD principal investigator
Fudan University
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 anti-PD-1 antibody in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital 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 16 inclusion and 21 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 19 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao-Chong Zeng, PhD (86-64041990-2764, zeng.zhaochong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 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 19 Mar 2019.