Stomach NeoplasmPhase 2NCT05184803
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
A Phase 2 study testing Docetaxel injection, oxaliplatin, S-1 in people with Stomach Neoplasm, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Docetaxel injection, oxaliplatin, S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2022to 31 Dec 2027
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven metastatic gastric adenocarcinoma patients
- As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B)
- Over 18 years old.
- Patients with a life expectancy of at least 3 months.
- Patients with 0 or 1 ECOG performance status
- As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function:
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- Haemoglobin 9 9.0 g/dL.
- Absolute neutrophil count (ANC) > 1.5 x 103/mCL (> 1,500 per mm3)
- Platelet count 100 100 x 109/L
- Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN).
- AST(SGOT)/ALT(SGPT) 2.5 2.5x ULN of test institution.
- Measured creatinine clearance (CL) > 40 mL/min or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates.
- Male creatinine CL (mL/min) = Weight (kg)x (140-age) / 72x Serum creatinine (mg/dL)
- Women's creatinine CL (mL/min) = Weight (kg)x (140-age) / 72 x Serum creatinine (mg/dL) x 0.85
- A patient who has never had chemotherapy before.
- Patients who have not previously had radiation therapy experience
- Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study.
- Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are considered menopause. In addition, if bilateral ovarian resection, bilateral ovariectomy, and hysterectomy are performed, menopause is considered.
- Subjects who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's legal representative prior to implementing the plan-related procedures, including screening evaluation.
Who cannot join
- When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.
- Cancer other than adenocarcinoma.
- Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.
- History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)
- Central nervous system metastasis.
- Clinically significant intestinal obstruction or gastrointestinal bleeding.
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- A patient with a history of organ transplantation.
- Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards.
- Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable)
- Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed.
- HBV DNA 500 500iu/ml (or 2500 copies/ml): Excluded
- HBV DNA ▶500iu/ml (or 2500 copies/ml): Allow
- Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed.
- If HCV RNA is positive, I'll exclude it.
- If it's HCV RNA's voice, it's allowed.
- HIV: HIV Ag/Ab : excluding reactive faces, HIV Ag/Ab : non-reactive faces registration
- Average QTcF (average QT interval for heart rate correction using fridericia formula) > 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals).
- If -1 test is performed and QTcF > 470 ms, 2 additional tests are performed to determine the average QTcF value.
- -If QTcF 4 470 ms after one test, no additional test is performed.
- Other serious diseases or medical conditions.
- Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study.
- A history of neurological or psychiatric diseases including dementia or seizures.
- Active, non-regulatory infection.
- Clinically serious diarrhea.
- Severe high calcium conditions above 12 mg/dL, which are not controlled by phonates.
- Other serious medical conditions that may affect participation in this study.
- Active random intravascular coagulation.
- Patients who other researchers find inappropriate.
- In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (<20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before the start of the study) as preventive therapy,
- In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination.
- Combination chemotherapy, hormone therapy, or immunotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, 138-736
Yoon-Koo Kang, MD, PhD, +82-2-3010-3230, ykkang@amc.seoul.kr
Min-Hee Ryu, MD, PhD, +82-2-3010-5935, miniryu@amc.seoul.kr
About this study
Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity.
In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases.
Read more
Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%).
We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%.
Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes.
Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.
- Conditions
- Stomach Neoplasm
- Being tested
- Docetaxel injection, oxaliplatin, S-1
- Keywords
- Neo-adjuvant/Adjuvant, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel injection, oxaliplatin, S-1Drug
As a prior chemotherapy, intravenous administration is performed every 3 weeks for docetaxel 50 mg/m2 D1, intravenous administration for oxaliplatin 100 mg/m2 D1, and oral administration twice a day for S-140 mg/m2 D1 to 14.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | treatment arm(docetaxel, oxaliplatin, S-1) Receives: Drug: Docetaxel injection, oxaliplatin, S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Evaluation of R0 resection rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Hee Ryu, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184803
- Sponsor's protocol ID
- AMC2201
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
- ClinicalTrials.gov ID
- NCT05184803
- Acronym / sponsor ID
- AMC2201
- Conditions
- Stomach Neoplasm
- Keywords
- Neo-adjuvant/Adjuvant, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jan 2022 (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.
Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity.
In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases.
Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%).
We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%.
Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes.
Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Docetaxel injection, oxaliplatin, S-1treatment arm(docetaxel, oxaliplatin, S-1) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically proven metastatic gastric adenocarcinoma patients
- As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B)
- Over 18 years old.
- Patients with a life expectancy of at least 3 months.
- Patients with 0 or 1 ECOG performance status
Key exclusion criteria (31 listed)
- When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.
- Cancer other than adenocarcinoma.
- Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.
- History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)
- Central nervous system metastasis.
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 |
|---|---|---|
| Docetaxel injection, oxaliplatin, S-1As a prior chemotherapy, intravenous administration is performed every 3 weeks for docetaxel 50 mg/m2 D1, intravenous administration for oxaliplatin 100 mg/m2 D1, and oral administration twice a day for S-140 mg/m2 D1 to 14. | Drug | treatment |
Primary outcome
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Time frame: 1 year
Evaluation of R0 resection rate.
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
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 Docetaxel injection, oxaliplatin, S-1 in people with Stomach Neoplasm, run by Asan Medical Center at 1 site in South Korea.
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 31 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 7 Apr 2026. 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 South Korea. 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?
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?
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?
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial. (time frame: 1 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 7 Apr 2026.