Nasopharyngeal NeoplasmsPhase 2NCT02902432

A Trial of Endostar in Patients With Carcinoma of the Head and Neck

A Phase 2 study testing Endostar in people with Nasopharyngeal Neoplasms, run by China International Medical Foundation at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nasopharyngeal Neoplasms
What is being tested?: Endostar
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteChina
Study dates: Jun 2016to Jan 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck;
No prior radiation or chemotherapy and biotherapy before;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months;
Patients must have adequate bone marrow function:
Platelets ≥ 80×109/L
Hemoglobin ≥100 g/L

Show all 15Show fewer

Absolute NeutrophilCount ≥1.5×109/L
white blood cell≥ 3.5×109/L
Patients must have adequate liver and renal function:
Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 × upper limit of normal
Alkaline phosphatase < 2.5 × upper limit of normal
Total bilirubin < 1.5 mg/dL
Creatinine <1.5 mg/dL× upper limit of normal
A cardiac ejection fraction > 50%;
Ability to understand and willingness to sign a written informed consent.

Who cannot join

Participation in any investigational drug study within 4 weeks preceding the start of study treatment;
Age ≤18 or ≥75 years of Age;
Pregnant or breastfeeding women;
Serious, uncontrolled, concurrent infection(s) requiring antibiotics;
Clinically apparent central nervous system metastases or carcinomatous meningitis;
Treatment for other carcinomas within the last 3 months;
Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory;
Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.

Trial locations and contacts

1 site in 1 country.

China1 site

the Second Xiangya Hospital
Changsha, Hunan, 410011

Other trials in China

About this study

The purpose of this study is to evaluate the efficacy and safety of recombinant human endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.

Read the detailed description

The patients will be randomized to CRT arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.

Prior to enrollment in this study and while the patient is receiving the therapy, routine tests, ECG, head and neck CT scan and MRI will be performed to check the body's response to the treatment. Further more, before and after the treatment, the circulating endothelial cells (CECs), endothelial progenitor cells (CEPs), vascular endothelial growth factor (VEGF), Cancer embryo antigen (CEA), Neuron-specific enolase (NSE) in blood and Microvessel density (MVD), hypoxia-inducible factor-1a (HIF-1a), P53, VEGF, Survivin in pathological specimens will be tested.

Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 4 cycles.

Primary outcome: The response rate (RR), the clinical benefit rate (CBR), time of tumor progression (TTP).

Secondary outcomes: The quality of life (QOL)，Safety and Tolerability.

Conditions: Nasopharyngeal Neoplasms
Being tested: Endostar
Keywords: endostar, cisplatin
Medical subject headings: Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EndostarDrug
Also called recombinant human endostatin
The patients will be randomized to CRT arm and CRT+Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT.

Study groups in NCT02902432
Study group	Role	What they receive
SCCHN	Placebo comparator	patients with advanced squamous cell carcinoma of the head and neck.IMRT. Receives: Drug: Endostar
SCCHN-Endostar	Experimental	patients with advanced squamous cell carcinoma of the head and neck.Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week(d-5-d-1, d3-d7, d10-d14, d17-d21)during IMRT. Receives: Drug: Endostar

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (Mon); PFS, According to RECIST v1.1
Time of tumor progression in patients with head and neck squamous cell carcinoma
Measured: up to 40 months

Secondary outcomes (1)

Quality of life (QOL); Scores range from 0 to 5
Quality of life (QOL) in cancer patients
Measured: up to 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Jan 2019

First posted15 Sep 2016 (estimated)
Study startJun 2016
Primary completion20 Dec 2017
Study completionJan 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal 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: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02902432
Sponsor's protocol ID: ChinaIMF
Status last verified: Jan 2019
First submitted: 12 Aug 2016
Last updated: 31 Jan 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma

All Nasopharyngeal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial of Endostar in Patients With Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT02902432
Acronym / sponsor ID: ChinaIMF
Conditions: Nasopharyngeal Neoplasms
Keywords: endostar, cisplatin
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (actual)
Lead sponsor: China International Medical FoundationUniversity, hospital or other
Collaborators: Chinese Society of Clinical Oncology
Study start: Jun 2016
Primary completion: 20 Dec 2017 (actual)
Study completion: Jan 2019 (estimated)
First posted: 15 Sep 2016 (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.

Detailed description

Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 4 cycles.

Primary outcome: The response rate (RR), the clinical benefit rate (CBR), time of tumor progression (TTP).

Secondary outcomes: The quality of life (QOL)，Safety and Tolerability.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SCCHN	Placebo comparator	Drug: Endostarpatients with advanced squamous cell carcinoma of the head and neck.IMRT.
SCCHN-Endostar	Experimental	Drug: Endostarpatients with advanced squamous cell carcinoma of the head and neck.Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week(d-5-d-1, d3-d7, d10-d14, d17-d21)during IMRT.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck;
No prior radiation or chemotherapy and biotherapy before;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months;
Patients must have adequate bone marrow function:
Patients must have adequate liver and renal function:

Key exclusion criteria (8 listed)

Participation in any investigational drug study within 4 weeks preceding the start of study treatment;
Age ≤18 or ≥75 years of Age;
Pregnant or breastfeeding women;
Serious, uncontrolled, concurrent infection(s) requiring antibiotics;
Clinically apparent central nervous system metastases or carcinomatous meningitis;

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
EndostarAlso: recombinant human endostatinThe patients will be randomized to CRT arm and CRT+Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT.	Drug	SCCHN, SCCHN-Endostar

Primary outcome

Progression-Free Survival (Mon); PFS, According to RECIST v1.1
Time frame: up to 40 months
Time of tumor progression in patients with head and neck squamous cell carcinoma

1 secondary outcome

Quality of life (QOL); Scores range from 0 to 5
Time frame: up to 40 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Individual participant dataSharing planned: Undecided

Related trials for Nasopharyngeal Neoplasms

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma

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.

ping liu, doctor principal investigator

Second Xiangya Hospital of Central South 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 Endostar in people with Nasopharyngeal Neoplasms, run by China International Medical Foundation 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 15 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 31 Jan 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (Mon); PFS, According to RECIST v1.1 (time frame: up to 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02902432.

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 31 Jan 2019.