Gastric Cancer, Gastroesophageal Junction CancerNCT06760858
A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Southwest Hospital, China at 2 sites in China.
Trial summary
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows: To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Tislelizumab, SOX and HIPEC
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 122 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2024to 1 Sep 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed Her-2 negative gastric adenocarcinoma，Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk
Who may be able to join
- Patients with newly diagnosed Her-2 negative gastric adenocarcinoma, with no prior chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.
- Age between 18 to 80 years old, Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
- Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk.
- Good bone marrow reserve function, with the following blood criteria: white blood cell count ≥3×10^9/L, neutrophils ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L.
- Good organ function, with the following biochemical criteria: aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min.
- International normalized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 times ULN.
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- Urine protein <2+, if urine protein ≥2+ then 24-hour urine protein quantification must be ≤1g.
- Consent to provide blood and tissue samples.
- Expected survival of more than 3 months.
- Female subjects agree to strict contraception; male subjects with partners of childbearing potential agree to use effective contraception during the study period.
- Voluntarily sign the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures.
Who cannot join
- Participants who have been enrolled in any other drug clinical trial or have participated in any drug clinical trial within the last month.
- Any anti-cancer treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than the study medication (palliative external beam radiation for non-target lesions is allowed).
- Prior use of similar chemotherapy drugs or immune checkpoint inhibitors.
- Presence of metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, or pelvic and abdominal cavity.
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months prior to enrollment.
- Other untreated or concurrent tumors, except for cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients with tumors that have been cured and have no evidence of disease for more than 5 years may be included. All other tumors must have been treated at least 5 years prior to enrollment.
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- Symptomatic meningiomas：
- History of active autoimmune diseases or refractory autoimmune diseases.
- Received corticosteroids (>10mg/day prednisone or equivalent dose of steroids) or other systemic immunosuppressive therapy within 14 days prior to enrollment, excluding the following treatments: steroid hormone replacement therapy (≤10mg/day); local steroid therapy; and short-term prophylactic steroid therapy for allergies or nausea and vomiting.
- History of HIV infection or active hepatitis B/C virus infection.
- Persistent > Grade 2 bacterial, fungal, viral infections.
- Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA) Class II;
- Active coronary artery disease;
- Arrhythmias requiring treatment other than beta-blockers or digoxin;
- Unstable angina (angina symptoms at rest), new-onset angina within 3 months prior to enrollment, or unhealed wounds, ulcers, or fractures due to myocardial infarction within 6 months prior to enrollment.
- Patients with renal failure requiring hemodialysis or peritoneal dialysis.
- Patients requiring medication for epilepsy.
- History of organ transplantation (including corneal transplants).
- Allergy to the study medication or similar drugs, or suspected allergies.
- Pregnant or breastfeeding women.
- Major surgery, open biopsy, or significant traumatic surgery within 4 weeks prior to recruitment.
- History of vaccination within 4 weeks prior to enrollment.
- Patients deemed unsuitable for the study by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400038
Yan Shi Mr. Shi Yan, doctorate, +86 13752909448, Shiyan@163.com
- Not yet recruiting
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400084
Yan Shi, +86 13752909448, shiyandoctor@sina.com
About this study
Official title: A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer with SOX Plus Tislelizumab Combined with HIPEC
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows:
To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab and HIPEC.
Read more
To assess the major pathological response (MPR) in these patients. Secondary objectives include safety, pathological complete response (pCR), progression-free survival (PFS), tumor regression grade (TRG), overall survival (OS), incidence of adverse reactions during treatment, postoperative adverse reactions, and treatment efficacy.
Participants will:
Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo HIPEC followed by SOX and Tislelizumab to achieve stable disease (SD), partial response (PR), or complete response (CR). Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, a multidisciplinary team (MDT) discussion will follow to determine the next treatment plan. Patients with progressive disease (PD) will also have an MDT discussion to determine the subsequent treatment.
Be willing to receive SOX combined with HIPEC treatment (observation group), undergo HIPEC followed by SOX to achieve SD, PR, or CR. Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, an MDT discussion will follow to determine the next treatment plan. Patients with PD will also have an MDT discussion to determine the subsequent treatment.
Treatment details:
SOX: S-1 dosage based on body surface area (BSA): <1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. HIPEC: Docetaxel: 120mg, day 1, day 3.
- Being tested
- Tislelizumab, SOX, HIPEC
- Keywords
- neoadjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles.
SOXDrug
SOX: S-1 dosage based on body surface area (BSA): <1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.
HIPECDevice
HIPEC: Docetaxel: 120mg, day 1, day 3.
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival
The 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab combined with HIPEC
Measured: 3 years
Secondary outcomes (1)
MPR
Systemic SOX chemotherapy combined with Tislelizumab and HIPEC for locally advanced gastric cancer patients' major pathological response (MPR).
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 posted7 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Gastroesophageal Junction 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Shi, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760858
- Sponsor's protocol ID
- SYIO-01
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2024
- Last updated
- 7 Jan 2025
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer with SOX Plus Tislelizumab Combined with HIPEC
- ClinicalTrials.gov ID
- NCT06760858
- Acronym / sponsor ID
- SYIO-01
- Keywords
- neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 7 Jan 2025 (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 clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows:
To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab and HIPEC.
To assess the major pathological response (MPR) in these patients. Secondary objectives include safety, pathological complete response (pCR), progression-free survival (PFS), tumor regression grade (TRG), overall survival (OS), incidence of adverse reactions during treatment, postoperative adverse reactions, and treatment efficacy.
Participants will:
Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo HIPEC followed by SOX and Tislelizumab to achieve stable disease (SD), partial response (PR), or complete response (CR). Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, a multidisciplinary team (MDT) discussion will follow to determine the next treatment plan. Patients with progressive disease (PD) will also have an MDT discussion to determine the subsequent treatment.
Be willing to receive SOX combined with HIPEC treatment (observation group), undergo HIPEC followed by SOX to achieve SD, PR, or CR. Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, an MDT discussion will follow to determine the next treatment plan. Patients with PD will also have an MDT discussion to determine the subsequent treatment.
Treatment details:
SOX: S-1 dosage based on body surface area (BSA): <1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. HIPEC: Docetaxel: 120mg, day 1, day 3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed Her-2 negative gastric adenocarcinoma，Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk
Key inclusion criteria (11 listed)
- Patients with newly diagnosed Her-2 negative gastric adenocarcinoma, with no prior chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.
- Age between 18 to 80 years old, Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
- Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk.
- Good bone marrow reserve function, with the following blood criteria: white blood cell count ≥3×10^9/L, neutrophils ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L.
- Good organ function, with the following biochemical criteria: aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min.
Key exclusion criteria (24 listed)
- Participants who have been enrolled in any other drug clinical trial or have participated in any drug clinical trial within the last month.
- Any anti-cancer treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than the study medication (palliative external beam radiation for non-target lesions is allowed).
- Prior use of similar chemotherapy drugs or immune checkpoint inhibitors.
- Presence of metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, or pelvic and abdominal cavity.
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months prior to enrollment.
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 |
|---|---|---|
| TislelizumabTislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. | Drug | – |
| SOXSOX: S-1 dosage based on body surface area (BSA): <1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles. | Drug | – |
| HIPECHIPEC: Docetaxel: 120mg, day 1, day 3. | Device | – |
Primary outcome
3-year disease-free survival
Time frame: 3 years
The 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab combined with HIPEC
1 secondary outcome
MPR
Time frame: 1 year
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 Jan 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Southwest Hospital, China at 2 sites 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 24 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Yan Shi, doctor (+86 13752909448, shiyandoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-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 7 Jan 2025.