Gastric CancerPhase 2MATCHNCT02725424
Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
A Phase 2 study testing S-1, Trastuzumab and Oxaliplatin in people with Gastric Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1, Trastuzumab and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;
- The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
- HER2 positive: IHC 3+ or IHC 2+/ FISH amplification.
- HER2 negative: IHC 0, 1+ or IHC 2+/ FISH without amplification.
- T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
- Chemotherapy and radiotherapy naïve.
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- Age ≥18 years;
- ECOG(Eastern Cooperative Oncology Group ) 0-1;
- Adequate hematological, hepatic and renal functions: absolute neutrophil count (ANC) ≥ 2.0 G/L, hemoglobin ≥ 90g/L, platelet ≥ 100 G/L; ALT and AST <1.5 times x upper limit of normal (ULN)；serum total bilirubin < 1.0 x ULN; serum creatinine < 1.0 x ULN;
- Left ventricular ejection fraction>50%
- Written informed consent.
Who cannot join
- Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma
- History of allergies to drugs in the study
- Intraperitoneal dissemination or distant metastasis
- Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites
- Dysphagia
- Any cause of cirrhosis
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- Cardiac function NYHA(New York Heart Association) >I degrees
- Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia
- Any surgical contraindication
- Any chemotherapy or radiotherapy history
- Any surgical resection history of gastric cancer
- History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix
- Any contraindication for chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 10000
About this study
Official title: A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status.
The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
Read the detailed description
(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
(HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
- Conditions
- Gastric Cancer
- Being tested
- S-1, Trastuzumab, Oxaliplatin, Docetaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called Oxaliplatin
Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.
TrastuzumabDrug
Also called Oxaliplatin, S-1
Her-2 positive patients with SOXT Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Trastuzumab: 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1 Every 3 weeks.
OxaliplatinDrug
Also called S-1
Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.
DocetaxelDrug
Also called Oxaliplatin, S-1
Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Her2 Positive with SOX | Active comparator | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. Receives: Drug: S-1; Drug: Oxaliplatin |
| Her2 Positive with SOXT | Experimental | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks. Receives: Drug: S-1; Drug: Trastuzumab; Drug: Oxaliplatin |
| Her2 Negative with SOX | Active comparator | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. Receives: Drug: S-1; Drug: Oxaliplatin |
| Her2 Negative with DOS | Experimental | Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. Receives: Drug: S-1; Drug: Oxaliplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
major Pathological response rate
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2018
- Study completionJun 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Ping Ai Zhou, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725424
- Sponsor's protocol ID
- CH-GI-071
- Acronym
- MATCH
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2016
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT02725424
- Acronym / sponsor ID
- MATCH / CH-GI-071
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Apr 2016 (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.
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status.
The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
Detailed description
(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
(HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Her2 Positive with SOX | Active comparator | Drug: S-1, Drug: OxaliplatinOxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
| Her2 Positive with SOXT | Experimental | Drug: S-1, Drug: Trastuzumab, Drug: OxaliplatinOxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks. |
| Her2 Negative with SOX | Active comparator | Drug: S-1, Drug: OxaliplatinOxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
| Her2 Negative with DOS | Experimental | Drug: S-1, Drug: Oxaliplatin, Drug: DocetaxelDocetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;
- The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
- T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
- Chemotherapy and radiotherapy naïve.
- Age ≥18 years;
Key exclusion criteria (13 listed)
- Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma
- History of allergies to drugs in the study
- Intraperitoneal dissemination or distant metastasis
- Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites
- Dysphagia
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 |
|---|---|---|
| S-1Also: OxaliplatinHer-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks. | Drug | Her2 Negative with DOS, Her2 Negative with SOX, Her2 Positive with SOX, Her2 Positive with SOXT |
| TrastuzumabAlso: Oxaliplatin, S-1Her-2 positive patients with SOXT Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Trastuzumab: 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1 Every 3 weeks. | Drug | Her2 Positive with SOXT |
| OxaliplatinAlso: S-1Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks. | Drug | Her2 Negative with DOS, Her2 Negative with SOX, Her2 Positive with SOX, Her2 Positive with SOXT |
| DocetaxelAlso: Oxaliplatin, S-1Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA <1.25m2) , 100mg(BSA ≥1.25m2, <1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks | Drug | Her2 Negative with DOS |
Primary outcome
major Pathological response rate
Time frame: 40 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Ping Ai Zhou, MD principal investigator
Chinese Academy 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 S-1, Trastuzumab and Oxaliplatin in people with Gastric Cancer, 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 11 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: finished, as of the sponsor's last update on 17 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major Pathological response rate (time frame: 40 months). 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 17 Aug 2022.