Hepatocellular CarcinomaPhase 2NCT03208335
Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
A Phase 2 study testing recombinant human endostatin in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- recombinant human endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP>250ug/l
- Inoperable and untransplantable,Child-pugh score A or B
- PS score 0-1
- At least one measurable site(diameter >20mm measured by CT or MRI,>10mm measured by helical CT scan.
- No distant metastases
- Life expectancy longer than 3 months
- Willingness and ability to comply the study and signed informed consent.
Who cannot join
- Not comply the designed treatment or change to other treatment
- Miss follow-up visits or have incomplete follow-up data
- The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.
- Disease progression
- Patients request to withdraw
- Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA Gereral Hospital
Beijing, Beijing Municipality, 100000
Yu Li, MD, +86 15801570739, szy957@aliyun.com
About this study
Official title: A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- recombinant human endostatin
- Keywords
- rh-endostatin, radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human endostatinDrug
Also called rh-endostatin
The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| rh-endostatin combination | Experimental | Continuous intravenous pumping (CIP) recombinant human endostatin(rh-endostatin) 30mg/d, from 5 days before radiotherapy,for 7days,21 per cycle.Standard radiotherapy for HCC is conducted concurrently.Those patients will receive 3-5 cycles rh-endostatin after the radiotherapy is finished,4-6 cycles in all. Receives: Drug: recombinant human endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress-free survival(PFS)
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Measured: 18 months
Secondary outcomes (5)
response rate(RR)
CR(complete response)+PR(partial response)
Measured: 18months
clinical benefit rate(CBR)
CR+PR+SD(stable disease)
Measured: 24months
overall survival(OS)
Overall survival was defined as the time from randomization to death from any cause.
Measured: 36 months
adverse event(AE)
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Measured: 36 months
Quality of life (QOL)
A questionnaire with questions referred to simple assessments of physical abilities
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (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 Chinese PLA General 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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YuLi, Chinese PLA General Hospital
- Investigators
- Yu Li, MD, Principal investigator, China PLA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208335
- Sponsor's protocol ID
- ChinaPLAGH-HCC
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03208335
- Acronym / sponsor ID
- ChinaPLAGH-HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- rh-endostatin, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Jul 2017 (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.
Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rh-endostatin combination | Experimental | Drug: recombinant human endostatinContinuous intravenous pumping (CIP) recombinant human endostatin(rh-endostatin) 30mg/d, from 5 days before radiotherapy,for 7days,21 per cycle.Standard radiotherapy for HCC is conducted concurrently.Those patients will receive 3-5 cycles rh-endostatin after the radiotherapy is finished,4-6 cycles in all. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP>250ug/l
- Inoperable and untransplantable,Child-pugh score A or B
- PS score 0-1
- At least one measurable site(diameter >20mm measured by CT or MRI,>10mm measured by helical CT scan.
- No distant metastases
Key exclusion criteria (6 listed)
- Not comply the designed treatment or change to other treatment
- Miss follow-up visits or have incomplete follow-up data
- The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.
- Disease progression
- Patients request to withdraw
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 |
|---|---|---|
| recombinant human endostatinAlso: rh-endostatinThe cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance. | Drug | rh-endostatin combination |
Primary outcome
progress-free survival(PFS)
Time frame: 18 months
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
5 secondary outcomes
response rate(RR)
Time frame: 18months
clinical benefit rate(CBR)
Time frame: 24months
overall survival(OS)
Time frame: 36 months
adverse event(AE)
Time frame: 36 months
Quality of life (QOL)
Time frame: 36months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yu Li, MD principal investigator
China PLA hospital
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 recombinant human endostatin in people with Hepatocellular Carcinoma, run by Chinese PLA General 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 7 inclusion and 6 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 5 Jul 2017. 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 Yu Li, MD (+86 15801570739, szy957@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress-free survival(PFS) (time frame: 18 months). 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 5 Jul 2017.