Gastric CancerPhase 3NCT03801668
Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
A Phase 3 study testing Albumin-bound Paclitaxel plus S-1 and Oxaliplatin plus S-1 in people with Gastric Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma. 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?
- Albumin-bound Paclitaxel plus S-1 and Oxaliplatin plus S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2019to 31 Mar 2023
- Phase
- Phase 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
- Age of 18-75 years;
- Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
- At least one measurable lesion as defined by RECIST 1.1 criteria;
- ECOG performance status of 0-1;
- Estimated life expectancy of at least 3 months;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
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- Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
- Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
- Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
- Able and willing to comply with the study plans in this protocol and sign the informed consent;
Who cannot join
- Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
- HER-2 positive;
- Patients with symptomatic brain metastases;
- II-IV peripheral neuropathy [NCI-CTCAE 4.03];
- Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
- Patients with serious systemic infection or other diseases;
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- Allergic to the chemotherapy drugs or the materials in this study;
- Patients with gastrointestinal bleeding that need clinical intervention;
- Patients with digestive tract obstruction or oral nutrition difficulty;
- Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
- Have participated in other clinical trials within 28 days prior to the first dose of this study;
- Contraindications to chemotherapy;
- Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xianglin Yuan, MD,PHD, 8627-83663406, xlyuan1020@163.com
Hong Qiu, MD,PHD, 8627-83663406, tjqiuhong@163.com
About this study
Official title: A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
- Conditions
- Gastric Cancer
- Being tested
- Albumin-bound Paclitaxel plus S-1, Oxaliplatin plus S-1
- Keywords
- Gastric Cancer, Albumin-bound Paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound Paclitaxel plus S-1Drug
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
Oxaliplatin plus S-1Drug
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Nab-P/S-1 | Experimental | Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1. Receives: Drug: Albumin-bound Paclitaxel plus S-1 |
| SOX | Active comparator | Patients in this arm receive chemotherapy with Oxaliplatin plus S-1. Receives: Drug: Oxaliplatin plus S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death.
Measured: up to 3 years
Secondary outcomes (3)
Overall Response Rate (ORR)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: up to 3 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Measured: up to 3 years
Safety as measured by number and grade of adverse events
Summary adverse events according to NCI-CTCAE 4.03
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start8 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 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.
- More trials run by Huazhong University of Science and TechnologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, MD,PhD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801668
- Sponsor's protocol ID
- TJCC008
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022.
PubMed 35983025
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03801668
- Acronym / sponsor ID
- TJCC008
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Albumin-bound Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 11 Jan 2019 (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.
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-P/S-1 | Experimental | Drug: Albumin-bound Paclitaxel plus S-1Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1. |
| SOX | Active comparator | Drug: Oxaliplatin plus S-1Patients in this arm receive chemotherapy with Oxaliplatin plus S-1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age of 18-75 years;
- Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
- At least one measurable lesion as defined by RECIST 1.1 criteria;
- ECOG performance status of 0-1;
- Estimated life expectancy of at least 3 months;
Key exclusion criteria (13 listed)
- Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
- HER-2 positive;
- Patients with symptomatic brain metastases;
- II-IV peripheral neuropathy [NCI-CTCAE 4.03];
- Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
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 |
|---|---|---|
| Albumin-bound Paclitaxel plus S-1Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. | Drug | Nab-P/S-1 |
| Oxaliplatin plus S-1Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. | Drug | SOX |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 3 years
PFS is defined as time from the start of treatment to progression of disease or death.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
Safety as measured by number and grade of adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 35983025Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022.
- 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.
Xianglin Yuan, MD,PhD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin-bound Paclitaxel plus S-1 and Oxaliplatin plus S-1 in people with Gastric Cancer, run by Huazhong University of Science and Technology 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 10 inclusion and 13 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 Jan 2022. 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 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 Xianglin Yuan, MD,PhD (8627-83663406, xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 3 years). 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 NCT03801668, 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 4 Jan 2022.