Quality of LifePhase 2/3EXECCNCT03577392
Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
A Phase 2/3 study testing oxaliplatin + capecitabine (XELOX chemotherapy) and rebombniant human endostatin in people with Quality of Life, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- oxaliplatin + capecitabine (XELOX chemotherapy) and rebombniant human endostatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Aug 2021
- Phase
- Phase 2/3
- 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
- Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
- There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.
- Male or female , age 18～75
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The patients had to have a life expectancy of at least 3 months.
- A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.
- Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l.
- Informed consent was obtained from all patients.
Who cannot join
- Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
- a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
- patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People Hospital
Chengdu, Sichuan, 61007
ke xie, MD PhD
Xiong jingyan
About this study
Official title: Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.
- Conditions
- Quality of Life
- Being tested
- oxaliplatin + capecitabine (XELOX chemotherapy), rebombniant human endostatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin + capecitabine (XELOX chemotherapy)Drug
Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
rebombniant human endostatinDrug
Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
| Study group | Role | What they receive |
|---|---|---|
| XELOX chemotherapy with recombinant human endotatin | Experimental | Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume. Receives: Drug: oxaliplatin + capecitabine (XELOX chemotherapy); Drug: rebombniant human endostatin |
| XELOX chemotherapy without recombinant human endotatin | Active comparator | Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15. Receives: Drug: oxaliplatin + capecitabine (XELOX chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
Measured: 4 years
Secondary outcomes (2)
local control
To describe local control and out-of-field disease progression
Measured: 4 years
Overall survival
comparison to maintenance XELOX chemotherapy alone.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, ming zeng, MD, Sichuan Provincial People's Hospital
- Investigators
- Ke Xie, MD PhD, Study chair, Sichuan Provincial People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577392
- Sponsor's protocol ID
- SIM-ED-1512
- Acronym
- EXECC
- Status last verified
- Apr 2019
- First submitted
- 23 Jun 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03577392
- Acronym / sponsor ID
- EXECC / SIM-ED-1512
- Conditions
- Quality of Life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 5 Jul 2018 (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.
To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| XELOX chemotherapy with recombinant human endotatin | Experimental | Drug: oxaliplatin + capecitabine (XELOX chemotherapy), Drug: rebombniant human endostatinPatients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume. |
| XELOX chemotherapy without recombinant human endotatin | Active comparator | Drug: oxaliplatin + capecitabine (XELOX chemotherapy)Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
- There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.
- Male or female , age 18～75
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The patients had to have a life expectancy of at least 3 months.
Key exclusion criteria (3 listed)
- Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
- a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
- patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.
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 |
|---|---|---|
| oxaliplatin + capecitabine (XELOX chemotherapy)Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15. | Drug | XELOX chemotherapy with recombinant human endotatin, XELOX chemotherapy without recombinant human endotatin |
| rebombniant human endostatinEndostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume. | Drug | XELOX chemotherapy with recombinant human endotatin |
Primary outcome
Progression free survival
Time frame: 4 years
Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
2 secondary outcomes
local control
Time frame: 4 years
Overall survival
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Ke Xie, MD PhD study chair
Sichuan Provincial People Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing oxaliplatin + capecitabine (XELOX chemotherapy) and rebombniant human endostatin in people with Quality of Life, run by Sichuan Provincial People's 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 8 inclusion and 3 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 Apr 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ke Xie, MD PhD (008618981838382, 840246753@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 4 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 4 Apr 2019.