Locally Advanced Gastric AdenocarcinomaPhase 3NCT05813015
Study of Comparing of With and Without Sequential Therapy of S-1
A Phase 3 study testing Docetaxel and Tegafur-Gimeracil-Oteracil in people with Locally Advanced Gastric Adenocarcinoma and Chemotherapy Effect, run by Zhejiang University at 1 site in China.
Trial summary
The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Adenocarcinoma, Chemotherapy Effect
- What is being tested?
- Docetaxel and Tegafur-Gimeracil-Oteracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2023to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
- (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
- (3) No significant tumor recurrence or metastasis as assessed by imaging;
- (4) Age 18 years - 75 years;
- (5) ECOG score of 0 or 1;
- (6) Laboratory tests tolerant to chemotherapy;
- (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10^9/L, platelet count ≥ 80 × 10^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin < 1.5 times the upper limit of normal value, AST, ALT < 2.5 times the upper limit of normal value, creatinine < 1.5 times the upper limit of normal value.
Who cannot join
- (1) Other pathological types of tumors;
- (2) Pregnant or nursing women;
- (3) Those with a history of other malignant neoplastic disease in the last 5 years;
- (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
- (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
- (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc;
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- (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption;
- (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator;
- (9) Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only;
- (10) Those requiring immunosuppressive therapy for organ transplantation;
- (11) who have received other chemotherapy regimens
- (12) Those with uncontrolled severe infections, or other serious concomitant diseases;
- (13) Allergic to S-1 or any of the study drug components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hanzhou, Zhejiang, 310000
Xiaoli Jin, Doctor, 86-13605809870, Jinxiaoli@zju.edu.cn
About this study
Official title: Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer
The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is:
- The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy.
All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.
- Being tested
- Docetaxel, Tegafur-Gimeracil-Oteracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel 40mg/m2，every 21 days，6 cycles.
Tegafur-Gimeracil-OteracilDrug
Also called S-1
S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.
| Study group | Role | What they receive |
|---|---|---|
| DS-S group | Experimental | All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation. Receives: Drug: Docetaxel; Drug: Tegafur-Gimeracil-Oteracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Recurrence free survival
Measured: 3 years
Secondary outcomes (1)
Overall survival
Overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start28 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Chen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813015
- Sponsor's protocol ID
- ZRWC_GC_C001
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer
- ClinicalTrials.gov ID
- NCT05813015
- Acronym / sponsor ID
- ZRWC_GC_C001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Apr 2023 (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.
The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is:
- The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy.
All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-S group | Experimental | Drug: Docetaxel, Drug: Tegafur-Gimeracil-OteracilAll patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
- (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
- (3) No significant tumor recurrence or metastasis as assessed by imaging;
- (4) Age 18 years - 75 years;
- (5) ECOG score of 0 or 1;
Key exclusion criteria (13 listed)
- (1) Other pathological types of tumors;
- (2) Pregnant or nursing women;
- (3) Those with a history of other malignant neoplastic disease in the last 5 years;
- (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
- (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
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 |
|---|---|---|
| DocetaxelDocetaxel 40mg/m2，every 21 days，6 cycles. | Drug | DS-S group |
| Tegafur-Gimeracil-OteracilAlso: S-1S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation. | Drug | DS-S group |
Primary outcome
Recurrence free survival
Time frame: 3 years
Recurrence free survival
1 secondary outcome
Overall survival
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
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 Docetaxel and Tegafur-Gimeracil-Oteracil in people with Locally Advanced Gastric Adenocarcinoma and Chemotherapy Effect, run by Zhejiang University 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 7 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: looking for participants now, as of the sponsor's last update on 14 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Jin (+86-13605809870, Jinxiaoli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: 3 years). 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 14 Apr 2023.