Gastric CancerPhase 2NCT01180166
Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
A Phase 2 study testing nimotuzumab in people with Gastric Cancer and Concurrent Chemoradiotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Concurrent Chemoradiotherapy
- What is being tested?
- nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Sep 2013
- 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
- 18-75 years old, male or female
- Gastric cancer with measurable lesions, and the diameter is at least 1 cm
- Karnofsky score: at least 70
- Estimated survival: at least 6 months
- No prior target therapy or radiotherapy
- No severe hypertension, cardiac disease, or diabetes mellitus
- Normal blood routine and chemical tests
- Signed consent
Who cannot join
- Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- Extensive distant metastases
- Pregnancy or in lactation
- Allergic to 5-Fluorouracil
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ningning Lu, Doctor, +86 01087788280, ykyzlyy@hotmail.com
Jing Jin, M.D., +86 01087788280, jingjin1025@163.com
About this study
Official title: Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.
Read the detailed description
There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.
- Conditions
- Gastric Cancer, Concurrent Chemoradiotherapy
- Being tested
- nimotuzumab
- Keywords
- Gastric cancer, concurrent chemoradiotherapy, target therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
Also called Nimotuzumab injection, Tai Xin-sheng
200 milligram (mg) of nimotuzumab per week during radiation period
| Study group | Role | What they receive |
|---|---|---|
| nimotuzumab | Experimental | Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients. Receives: Drug: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
progression-free survival: the time between tumor regression to progression
Measured: 1 year progression-free survival
Secondary outcomes (2)
overall responses
the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system
Measured: 1 month after treatment
overall survival time
median overall survival time
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- jing jin, M.D., Principal investigator, Chinese Acedemy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180166
- Sponsor's protocol ID
- CH-GI-010
- Status last verified
- Sep 2013
- First submitted
- 3 Aug 2010
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT01180166
- Acronym / sponsor ID
- CH-GI-010
- Conditions
- Gastric Cancer, Concurrent Chemoradiotherapy
- Keywords
- Gastric cancer, concurrent chemoradiotherapy, target therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Aug 2010 (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.
The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.
Detailed description
There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nimotuzumab | Experimental | Drug: nimotuzumabCombination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old, male or female
- Gastric cancer with measurable lesions, and the diameter is at least 1 cm
- Karnofsky score: at least 70
- Estimated survival: at least 6 months
- No prior target therapy or radiotherapy
Key exclusion criteria (4 listed)
- Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- Extensive distant metastases
- Pregnancy or in lactation
- Allergic to 5-Fluorouracil
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 |
|---|---|---|
| nimotuzumabAlso: Nimotuzumab injection, Tai Xin-sheng200 milligram (mg) of nimotuzumab per week during radiation period | Drug | nimotuzumab |
Primary outcome
progression-free survival
Time frame: 1 year progression-free survival
progression-free survival: the time between tumor regression to progression
2 secondary outcomes
overall responses
Time frame: 1 month after treatment
overall survival time
Time frame: 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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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.
jing jin, M.D. principal investigator
Chinese Acedemy of Medical Sciences
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 nimotuzumab in people with Gastric Cancer and Concurrent Chemoradiotherapy, run by Chinese Academy of Medical Sciences 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 4 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 Sep 2013. 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 Ningning Lu, Doctor (+86 01087788280, ykyzlyy@hotmail.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: 1 year progression-free survival). 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 Sep 2013.