Gastric CancerPhase 2NCT04258657
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
A Phase 2 study testing paclitaxel-albumin and S-1 in people with Gastric Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- paclitaxel-albumin and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathologically diagnosed gastric adenocarcinoma
- Type II and III esophageal-gastric-junction malignancy
- AJCC stage II-III
- No contraindications for surgery, radical resection can be expected
- KPS>60; ECOG score:0-2
- Expactant survival period>6 months
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- Age 20~75
- No other major health issues
- Lab results within 7 days before inclusion must satisfy:
- neutrophil≥1.5×109/L
- PLT≥100×109/L
- hemogloblin≥90g/L
- ALT,AST<1.5 upper limit
- Tbil≤1.0×UNL
- serum creatinine<1.5×UNL
- PT-INR/PTT<1.7 upper limit
- with measurable lesion according to RECIST1.1 criteria
- with consent
- co-operative
Who cannot join
- with other major health issue
- allergic to relevant drugs
- experienced any other drug therapy with 4 weeks before inclusion
- experienced any drug therapy for gastric cancer at anytime
- diagnosed with any other malignancy within the past 5 years
- women at child-bearing age; pregnant or breast-feeding women
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- with severe heart disease
- with upper GI digestion or disrupted absorption
- with peripheral neural disease
- with transplated organs or organs having been resected for transplantation
- known DPD deficiency
- with uncontrolled infection
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongtao Zhang
Beijing, Beijing Municipality, 100050
Zhongtao Zhang, 8618811792819 ext. 8618811792819, zhongtao.z@139.com
About this study
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- paclitaxel-albumin and S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-albumin and S-1Drug
neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-albumin and S-1 | Experimental | Not described Receives: Drug: paclitaxel-albumin and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease free survival
Measured: 3-year
Secondary outcomes (2)
ORR
objective response rate
Measured: 3-year
OS
overall survival
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by Beijing Friendship 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Wei Deng, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258657
- Sponsor's protocol ID
- BFH-GCCT
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 6 Feb 2020
- 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 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04258657
- Acronym / sponsor ID
- BFH-GCCT
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Feb 2020 (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.
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-albumin and S-1 | Experimental | Drug: paclitaxel-albumin and S-1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- pathologically diagnosed gastric adenocarcinoma
- Type II and III esophageal-gastric-junction malignancy
- AJCC stage II-III
- No contraindications for surgery, radical resection can be expected
- KPS>60; ECOG score:0-2
Key exclusion criteria (12 listed)
- with other major health issue
- allergic to relevant drugs
- experienced any other drug therapy with 4 weeks before inclusion
- experienced any drug therapy for gastric cancer at anytime
- diagnosed with any other malignancy within the past 5 years
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 |
|---|---|---|
| paclitaxel-albumin and S-1neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer | Drug | Paclitaxel-albumin and S-1 |
Primary outcome
DFS
Time frame: 3-year
disease free survival
2 secondary outcomes
ORR
Time frame: 3-year
OS
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- 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.
Wei Deng study director
Beijing Friendship 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 paclitaxel-albumin and S-1 in people with Gastric Cancer, run by Beijing Friendship 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 19 inclusion and 12 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 6 Feb 2020. 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 Zhongtao Zhang (8618811792819 ext. 8618811792819, zhongtao.z@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 3-year). 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 6 Feb 2020.