Gastric CancerPhase 2NCT05052931
Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer
A Phase 2 study testing Nab-paclitaxel combined with oxaliplatin and S-1 in people with Gastric Cancer, run by Jianjun Yang at 1 site in China.
Trial summary
This is a prospective, single-center, open, historically controlled real-world study. The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Nab-paclitaxel combined with oxaliplatin and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2023
- 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
- Gastric adenocarcinoma diagnosed by histology.
- Ambulatory cases, 18-75 years old
- ECOG performance status ≤ 1
- Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
- Patients able to tolerate abdominal surgery above grade 3
- Has adequate organ function as defined by the following criteria:
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- WBC> 4.0×10^9/L
- ANC> 1.5×10^9/L
- ANC ≥ 1.5×10^9/L
- HB ≥ 80 g/L
- PLT ≥ 100×10^9/L
- TBIL ≤ 1.5×ULN
- ALT and AST <2.5 × ULN, for patients with liver metastases, ALT and AST <5 × ULN
- BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min
- No history of other tumors
- Be willing and able to comply with the plan during the research period
- Has given written informed consent
- Life expectancy ≥ 6 months
Who cannot join
- Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
- HER-2+ and willing to receive Trastuzumab
- Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period
- Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
- Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
- Patients with other surgical contraindications, such as serious diseases that are difficult to control
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- The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR > 1.5)
- Active HBV or HCV
- Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0
- Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of the Air Force Medical University
Xi'an
Jianjun Yang, 029-84771532, yangjj@fmmu.edu.cn
About this study
Official title: Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study
This is a prospective, single-center, open, historically controlled real-world study.
The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Nab-paclitaxel combined with oxaliplatin 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.
Nab-paclitaxel combined with oxaliplatin and S-1Drug
Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Nab-paclitaxel combined with oxaliplatin and S-1 Receives: Drug: Nab-paclitaxel combined with oxaliplatin and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
Measured: 2-year
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the rate of complete response (CR) or partial response (PR), as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion.
Measured: 7-month
Disease Control Rate (DCR)
The proportion of all subjects who assessed the best overall curative effect as CR, PR, and disease stable (SD) according to the RECIST 1.1 standard.
Measured: 7-month
Overall survival (OS)
It is defined as the time from the first doses durg to the time of death due to any reason.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianjun Yang
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Jianjun Yang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052931
- Sponsor's protocol ID
- CSPC-KIL-GC-006
- Status last verified
- Apr 2023
- First submitted
- 25 Aug 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zheng J, Wang S, Xu G, Wang J, Wang Y, Luo J, Wang Y, Yang J. A small-scale, exploratory real-world study of nab-paclitaxel combined with oxaliplatin and tegafur in the perioperative treatment of advanced gastric cancer: a study protocol for a real-world clinical trial. J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 2023 Apr 27.
PubMed 37201078
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study
- ClinicalTrials.gov ID
- NCT05052931
- Acronym / sponsor ID
- CSPC-KIL-GC-006
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jianjun YangUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Sep 2021 (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 prospective, single-center, open, historically controlled real-world study.
The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with 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 |
|---|---|---|
| treatment group | Experimental | Drug: Nab-paclitaxel combined with oxaliplatin and S-1Nab-paclitaxel combined with oxaliplatin and S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Gastric adenocarcinoma diagnosed by histology.
- Ambulatory cases, 18-75 years old
- ECOG performance status ≤ 1
- Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
- Patients able to tolerate abdominal surgery above grade 3
Key exclusion criteria (10 listed)
- Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
- HER-2+ and willing to receive Trastuzumab
- Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period
- Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
- Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
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 |
|---|---|---|
| Nab-paclitaxel combined with oxaliplatin and S-1Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy. | Drug | treatment group |
Primary outcome
AE
Time frame: 2-year
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
3 secondary outcomes
Objective response rate (ORR)
Time frame: 7-month
Disease Control Rate (DCR)
Time frame: 7-month
Overall survival (OS)
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 37201078Zheng J, Wang S, Xu G, Wang J, Wang Y, Luo J, Wang Y, Yang J. A small-scale, exploratory real-world study of nab-paclitaxel combined with oxaliplatin and tegafur in the perioperative treatment of advanced gastric cancer: a study protocol for a real-world clinical trial. J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 2023 Apr 27.
- 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.
The First Affiliated Hospital of the Air Force Medical University
Xi'an, China
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 Nab-paclitaxel combined with oxaliplatin and S-1 in people with Gastric Cancer, run by Jianjun Yang 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 18 inclusion and 10 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 13 Apr 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: 2-year). 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 NCT05052931, which also lists 1 linked publication.
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 13 Apr 2023.