Head and Neck NeoplasmsPhase 2NCT02283489
Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors
A Phase 2 study testing recombinant human endostatin adenovirus, Cisplatin injection and Paclitaxel injection in people with Head and Neck Neoplasms, run by Renmiao Zhang at 4 sites in China.
Trial summary
This study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- recombinant human endostatin adenovirus, Cisplatin injection and Paclitaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2014to Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced head and neck cancer unsuitable for surgery or radiotherapy (including head and neck squamous carcinoma and nasopharyngeal carcinoma, which should not more than 30%)
- Cytological and/or histopathologic diagnosis
- Target lesions can be treated with intratumor injection
- Lesions can be measured by imaging with a diameter of ≥2 cm (RECIST1.1)
- No chemotherapy, radiotherapy, or biotherapy administered in the past 4 weeks
- Age of 18 to 70 years
Show all 10Show fewer
- Life expectation of ≥12 weeks
- ECOG performance status of 0 to 2
- Laboratory examinations performed ≤7 days before enrollment with the following results: absolute neutrophil count of ≥1.5 × 109 L-1, platelet count of ≥80 × 109/L, total bilirubin level of ≤2 mg/dL, AST and ALT levels of ≤2 times the upper limit of the reference range, and coagulation parameters ≤1.5 times the upper limit of the reference range
- Voluntary participation and written informed consent
Who cannot join
- Allergy to EDS01
- Nerves and vessels passing through target lesions do not allow for injection of EDS01 into lesions
- Simultaneous radiation of target lesions
- Cancer recurrence within 6 months treated by paclitaxel
- Severe coagulation dysfunction and bleeding tendency
- Serious medical diseases, myocardial infraction in the past 3 months, or acute infection
- Currently pregnant or lactating
- Any conditions that the investigator regards as unsuitable for the study
Trial locations and contacts
4 sites in 1 country.
Renmiao Zhang contact
China4 sites, 4 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Liqun Zou, M.D.
Liqun Zou, M.D.
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Ke Xie, M.D.
Ke Xie, M.D.
- Recruiting
Chongqing Cancer Hospital
Chongqing, 400030
Xiaohong Zhou, M.D.
Xiaohong Zhou, M.D.
- Recruiting
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
Shanghai, 200011
Wei Guo, M.D.
Wei Guo, M.D.
About this study
Official title: Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors: Phase II, Multicenter, Randomized, Controlled Clinical Trial
This study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
Read the detailed description
Head and neck cancer is one of the most common malignant tumors in China, accounting for 19.9% to 30.2% of malignant tumors in this country. Approximately 60% to 70% of patients have stage III or IV disease at the time of diagnosis, and the 5-year overall survival is about 30%. The local recurrence rate ranges from 50% to 60%. The 5-year overall survival for patients treated with multidisciplinary treatment, which is a common treatment method that includes surgery, chemotherapy, radiotherapy, and biotherapy, has recently increased by 5%. Further improvements in the treatment effects of head and neck cancer are required.
Endostatin, an endogenous angiogenesis inhibitor and a C-terminal fragment of collagen XVIII, effectively inhibits tumor angiogenesis by specific inhibition of neovascular endothelial cells [7, 8]. Its characteristic antitumor effect is dose-dependent, requiring continuous high protein activity. Transportation of recombinant genes with adenovirus vectors into the body leads to continuous expression of high levels of endogenous secretory proteins, resolving the limitation of foreign protein infusion. Previous studies have shown that the antitumor activity of recombinant human endostatin adenovirus is higher than that of recombinant human endostatin protein.
EDS01, an antitumor gene therapy product that uses recombined adenovirus type 5 as the vector for the human endostatin gene, may be termed a recombinant adenovirus-recombined human endostatin gene. Intratumor injection of EDS01 reportedly results in transportation of the human endostatin gene into tumor cells by adenovirus infection, leading to the expression of endostatin protein. Expression of this protein inhibits neovascular endothelial cells, neovascularization, and tumor growth and metastasis. Both in vivo and in vitro experiments have shown that EDS01 significantly inhibits the growth of neovascular endothelial cells and tumor growth in nude mouse xenograft models of laryngocarcinoma and nasopharyngeal carcinoma.
A phase I clinical trial (No. treatment effect) conducted at West China Hospital of Sichuan University enrolled patients with superficial advanced head and neck cancer lesions. The patients underwent injection of different doses of EDS01, and the investigators performed a preliminary evaluation of the maximally tolerated dose and adverse events. The study showed that, whether administered by dose escalation or in multiple doses, EDS01 was well tolerated without dose-limiting toxicity and maximum tolerated dose. The main side effects were fever and injection site pain with flu-like symptoms. A small amount of EDS01 (1/10 000 000) was absorbed into the bloodstream. A thimbleful (1/100 000 000 to 1/10 000 000 000) was excreted in the urine and feces and was nontoxic to the environment. The target lesions exhibited a treatment response.
According to the results of this phase I trial, both 5.0 × 1011 and 1.0 × 1012 virus particles (VP) of EDS01 showed adequate safety and treatment responses. Therefore, in the subsequent phase II clinical trial, the optimal of these two doses will be determined. The treatment effects and safety of this protocol for head and neck cancer will also be further investigated.
In summary, this study will initially explore the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
In the experimental group, the target lesion is defined as that injected by EDS01. In the control group, the target lesion is defined as that selected at the inception.
- Conditions
- Head and Neck Neoplasms
- Being tested
- recombinant human endostatin adenovirus, Cisplatin injection, Paclitaxel injection
- Keywords
- Recombinant Human Endostatin Adenovirus, Head and Neck Malignant Tumor, clinical trial, randomized, Endostatin, gene therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human endostatin adenovirusDrug
Also called EDS01 (20140303)
Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL).
Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study.
Cisplatin injectionDrug
Specification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction.
Paclitaxel injectionDrug
Specification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy A | Experimental | Recombinant human endostatin adenovirus (EDS01), 5.0 × 1011 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. Receives: Drug: recombinant human endostatin adenovirus; Drug: Cisplatin injection; Drug: Paclitaxel injection |
| Combination therapy B | Experimental | Recombinant human endostatin adenovirus (EDS01), 1.0 × 1012 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. Receives: Drug: recombinant human endostatin adenovirus; Drug: Cisplatin injection; Drug: Paclitaxel injection |
| Chemotherapy | Experimental | Paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. Receives: Drug: Cisplatin injection; Drug: Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective response rate (ORR) of target lesion
Objective response rate (ORR) of target lesion is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR), , determined by tumor assessments from radiological tests including CT and MRI. CR is defined as disappearance of the target lesion. PR is defined as a decrease of at least 30% in the product of two perpendicular diameters of the target lesion.
Measured: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Secondary outcomes (4)
Change in Disease control rate of target lesion
The disease control rate of the target lesion includes CR, PR, and stable disease (SD). SD is defined as a decrease of <30% or an increase of <20% in the size of the target lesion, determined by tumor assessments from radiological tests including CT and MRI.
Measured: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Change in ORR of all lesions
All lesions include the target lesions, nontarget lesions, and new lesions. ORR of all lesions includes CR and PR.
Measured: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Time to progression
Time to progression is defined as the time from randomization until objective tumor progression as verified for the first time.
Measured: Up to 24 weeks
Change in Immune response
Serum IgG antibody responses to the respective viruses will be detected in blood samples. ELISA will be used to test the quantity of serum IgG in a central laboratory according to the specific provisions of the central laboratory. During the screening phase and on days 7, 21, 35, 48, 62, and 76, venous serum (3 mL) will be gathered in a drying tube by venipuncture. After 30 minutes, they will be centrifuged at 2 000 r/min for 10 minutes, and the supernatant will be stored at -80 °C for testing.
Measured: During the screening phase and on days 7, 21, 35, 48, 62, and 76 (day 1 is defined as the first day of chemotherapy with the TP regimen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmiao Zhang
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Renmiao Zhang, Chengdu Shi Endor Biological Engineering Technology Co., Ltd
- Investigators
- Renmiao Zhang, MD, PhD, Study director, Chengdu Shi Endor Biological Engineering Technology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283489
- Sponsor's protocol ID
- ChengduShiEn_RMZ_001
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors: Phase II, Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02283489
- Acronym / sponsor ID
- ChengduShiEn_RMZ_001
- Conditions
- Head and Neck Neoplasms
- Keywords
- Recombinant Human Endostatin Adenovirus, Head and Neck Malignant Tumor, clinical trial, randomized, Endostatin, gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Renmiao ZhangIndustry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- 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 study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
Detailed description
Head and neck cancer is one of the most common malignant tumors in China, accounting for 19.9% to 30.2% of malignant tumors in this country. Approximately 60% to 70% of patients have stage III or IV disease at the time of diagnosis, and the 5-year overall survival is about 30%. The local recurrence rate ranges from 50% to 60%. The 5-year overall survival for patients treated with multidisciplinary treatment, which is a common treatment method that includes surgery, chemotherapy, radiotherapy, and biotherapy, has recently increased by 5%. Further improvements in the treatment effects of head and neck cancer are required.
Endostatin, an endogenous angiogenesis inhibitor and a C-terminal fragment of collagen XVIII, effectively inhibits tumor angiogenesis by specific inhibition of neovascular endothelial cells [7, 8]. Its characteristic antitumor effect is dose-dependent, requiring continuous high protein activity. Transportation of recombinant genes with adenovirus vectors into the body leads to continuous expression of high levels of endogenous secretory proteins, resolving the limitation of foreign protein infusion. Previous studies have shown that the antitumor activity of recombinant human endostatin adenovirus is higher than that of recombinant human endostatin protein.
EDS01, an antitumor gene therapy product that uses recombined adenovirus type 5 as the vector for the human endostatin gene, may be termed a recombinant adenovirus-recombined human endostatin gene. Intratumor injection of EDS01 reportedly results in transportation of the human endostatin gene into tumor cells by adenovirus infection, leading to the expression of endostatin protein. Expression of this protein inhibits neovascular endothelial cells, neovascularization, and tumor growth and metastasis. Both in vivo and in vitro experiments have shown that EDS01 significantly inhibits the growth of neovascular endothelial cells and tumor growth in nude mouse xenograft models of laryngocarcinoma and nasopharyngeal carcinoma.
A phase I clinical trial (No. treatment effect) conducted at West China Hospital of Sichuan University enrolled patients with superficial advanced head and neck cancer lesions. The patients underwent injection of different doses of EDS01, and the investigators performed a preliminary evaluation of the maximally tolerated dose and adverse events. The study showed that, whether administered by dose escalation or in multiple doses, EDS01 was well tolerated without dose-limiting toxicity and maximum tolerated dose. The main side effects were fever and injection site pain with flu-like symptoms. A small amount of EDS01 (1/10 000 000) was absorbed into the bloodstream. A thimbleful (1/100 000 000 to 1/10 000 000 000) was excreted in the urine and feces and was nontoxic to the environment. The target lesions exhibited a treatment response.
According to the results of this phase I trial, both 5.0 × 1011 and 1.0 × 1012 virus particles (VP) of EDS01 showed adequate safety and treatment responses. Therefore, in the subsequent phase II clinical trial, the optimal of these two doses will be determined. The treatment effects and safety of this protocol for head and neck cancer will also be further investigated.
In summary, this study will initially explore the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
In the experimental group, the target lesion is defined as that injected by EDS01. In the control group, the target lesion is defined as that selected at the inception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination therapy A | Experimental | Drug: recombinant human endostatin adenovirus, Drug: Cisplatin injection, Drug: Paclitaxel injectionRecombinant human endostatin adenovirus (EDS01), 5.0 × 1011 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. |
| Combination therapy B | Experimental | Drug: recombinant human endostatin adenovirus, Drug: Cisplatin injection, Drug: Paclitaxel injectionRecombinant human endostatin adenovirus (EDS01), 1.0 × 1012 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. |
| Chemotherapy | Experimental | Drug: Cisplatin injection, Drug: Paclitaxel injectionPaclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced head and neck cancer unsuitable for surgery or radiotherapy (including head and neck squamous carcinoma and nasopharyngeal carcinoma, which should not more than 30%)
- Cytological and/or histopathologic diagnosis
- Target lesions can be treated with intratumor injection
- Lesions can be measured by imaging with a diameter of ≥2 cm (RECIST1.1)
- No chemotherapy, radiotherapy, or biotherapy administered in the past 4 weeks
Key exclusion criteria (8 listed)
- Allergy to EDS01
- Nerves and vessels passing through target lesions do not allow for injection of EDS01 into lesions
- Simultaneous radiation of target lesions
- Cancer recurrence within 6 months treated by paclitaxel
- Severe coagulation dysfunction and bleeding 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 |
|---|---|---|
| recombinant human endostatin adenovirusAlso: EDS01 (20140303)Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL). Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study. | Drug | Combination therapy A, Combination therapy B |
| Cisplatin injectionSpecification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction. | Drug | Chemotherapy, Combination therapy A, Combination therapy B |
| Paclitaxel injectionSpecification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction. | Drug | Chemotherapy, Combination therapy A, Combination therapy B |
Primary outcome
Change in Objective response rate (ORR) of target lesion
Time frame: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Objective response rate (ORR) of target lesion is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR), , determined by tumor assessments from radiological tests including CT and MRI. CR is defined as disappearance of the target lesion. PR is defined as a decrease of at least 30% in the product of two perpendicular diameters of the target lesion.
4 secondary outcomes
Change in Disease control rate of target lesion
Time frame: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Change in ORR of all lesions
Time frame: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).
Time to progression
Time frame: Up to 24 weeks
Change in Immune response
Time frame: During the screening phase and on days 7, 21, 35, 48, 62, and 76 (day 1 is defined as the first day of chemotherapy with the TP regimen)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
Renmiao Zhang contact
Renmiao Zhang, MD, PhD study director
Chengdu Shi Endor Biological Engineering Technology Co., Ltd
4 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 recombinant human endostatin adenovirus, Cisplatin injection and Paclitaxel injection in people with Head and Neck Neoplasms, run by Renmiao Zhang at 4 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 10 inclusion and 8 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 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renmiao Zhang (zrm_eds001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective response rate (ORR) of target lesion (time frame: During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 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 5 Nov 2014.