Gastric Cancer with Peritoneal MetastasisNCT06682182
Tislelizumab Combined with SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer with Peritoneal Metastasis: a Prospective Cohort Study
An observational study of Gastric Cancer with Peritoneal Metastasis, run by Southwest Hospital, China.
Trial summary
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating gastric cancer with peritoneal metastasis. The primary and secondary objectives are as follows: Primary objective: To evaluate the surgical conversion rate in patients with gastric cancer… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer with Peritoneal Metastasis
- What is being tested?
- Tislelizumab+SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2028
- 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 pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk. Peritoneal Cancer Index (PCI) ≤ 20.
Who may be able to join
- Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received 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.
- American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk.
- Peritoneal Cancer Index (PCI) ≤ 20. Good bone marrow reserve function, with blood routine meeting the following conditions: white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.
- Good organ function, with biochemical tests meeting the following conditions: Alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, blood 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 show protein ≤ 1g.
- Agreement to provide blood/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.
- Voluntary signing of the informed consent form, willingness and ability to comply with planned visits, study treatments, laboratory tests, and other trial procedures.
Who cannot join
- Patients who are receiving other drug clinical trials or have participated in any drug clinical trials within one month before enrollment.
- Other anti-tumor treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) except for study medication. Palliative external irradiation for non-target lesions is allowed.
- Prior use of similar chemotherapy drugs or immune checkpoint inhibitors. Presence of non-pelvic abdominal metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, etc.; patients with peritoneal metastasis in the small bowel mesentery (regions 9-12) must be excluded.
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months before enrollment.
- Other untreated or concurrent tumors, except for cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients may be enrolled if the tumor was cured and there has been no evidence of disease for more than 5 years. All other tumors must have been treated at least 5 years before enrollment.
- Symptomatic meningioma. History of active autoimmune disease or refractory autoimmune disease. Received corticosteroids (>10mg/day prednisone or equivalent dose of steroids) or other systemic immunosuppressive therapy within 14 days before enrollment, excluding the following treatments: steroid hormone replacement therapy (≤10mg/day); local steroid therapy; and short-term prophylactic steroid therapy for allergy or nausea and vomiting.
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- History of HIV infection or active hepatitis B/C virus infection. Persistent > Grade 2 bacterial, fungal, viral, or other infections.
- Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA) Class 2; 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 before enrollment, or new myocardial infarction with unhealed wounds, ulcers, or fractures within 6 months before enrollment.
- Patients with renal failure requiring hemodialysis or peritoneal dialysis. Patients requiring medication for epilepsy. History of organ transplantation (including corneal transplants). Allergy or suspected allergy to the study medication or similar drugs. Pregnant or breastfeeding women. Major surgery, open biopsy, or major traumatic surgery within 4 weeks before recruitment (excluding biliary stents or percutaneous biliary drainage).
- History of vaccination within 4 weeks before enrollment. Patients deemed unsuitable for the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating gastric cancer with peritoneal metastasis. The primary and secondary objectives are as follows:
Primary objective: To evaluate the surgical conversion rate in patients with gastric cancer peritoneal metastasis treated with systemic chemotherapy plus immune checkpoint inhibitors combined with HIPEC.
Read more
Secondary objectives: To assess the safety, overall survival (OS), progression-free survival, tumor regression rate, incidence of adverse reactions during treatment, postoperative adverse reaction rates, and treatment efficacy of the combination therapy.
Participants will:
Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo one session of HIPEC followed by SOX plus immune checkpoint inhibitors (two cycles) 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, the next treatment plan will be discussed in a multidisciplinary team (MDT) meeting. Patients with progressive disease (PD) will also have their next treatment plan discussed in an MDT meeting.
Be willing to receive SOX combined with HIPEC treatment (observation group), undergo one session of HIPEC followed by SOX (two cycles) 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, the next treatment plan will be discussed in an MDT meeting. Patients with PD will also have their next treatment plan discussed in an MDT meeting.
Treatment details:
SOX: S-1 dosing 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 6 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes.
- Being tested
- Tislelizumab+SOX
- Keywords
- Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab+SOXDrug
OX: S-1 dosing 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 6 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion surgery rate
Conversion surgery rate (the proportion of enrolled patients achieving R0 resection after treatment) for gastric cancer patients with peritoneal metastasis treated with Tislelizumab combined with HIPEC
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 posted12 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer with Peritoneal MetastasisStudies 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
- 74 participants (estimated)
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
- NCT06682182
- Sponsor's protocol ID
- SYIO-02
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined with SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer with Peritoneal Metastasis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06682182
- Acronym / sponsor ID
- SYIO-02
- Keywords
- Tislelizumab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 12 Nov 2024 (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 gastric cancer with peritoneal metastasis. The primary and secondary objectives are as follows:
Primary objective: To evaluate the surgical conversion rate in patients with gastric cancer peritoneal metastasis treated with systemic chemotherapy plus immune checkpoint inhibitors combined with HIPEC.
Secondary objectives: To assess the safety, overall survival (OS), progression-free survival, tumor regression rate, incidence of adverse reactions during treatment, postoperative adverse reaction rates, and treatment efficacy of the combination therapy.
Participants will:
Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo one session of HIPEC followed by SOX plus immune checkpoint inhibitors (two cycles) 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, the next treatment plan will be discussed in a multidisciplinary team (MDT) meeting. Patients with progressive disease (PD) will also have their next treatment plan discussed in an MDT meeting.
Be willing to receive SOX combined with HIPEC treatment (observation group), undergo one session of HIPEC followed by SOX (two cycles) 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, the next treatment plan will be discussed in an MDT meeting. Patients with PD will also have their next treatment plan discussed in an MDT meeting.
Treatment details:
SOX: S-1 dosing 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 6 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk. Peritoneal Cancer Index (PCI) ≤ 20.
Key inclusion criteria (9 listed)
- Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received 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.
- American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk.
- Peritoneal Cancer Index (PCI) ≤ 20. Good bone marrow reserve function, with blood routine meeting the following conditions: white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.
- Good organ function, with biochemical tests meeting the following conditions: Alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, blood creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min.
Key exclusion criteria (11 listed)
- Patients who are receiving other drug clinical trials or have participated in any drug clinical trials within one month before enrollment.
- Other anti-tumor treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) except for study medication. Palliative external irradiation for non-target lesions is allowed.
- Prior use of similar chemotherapy drugs or immune checkpoint inhibitors. Presence of non-pelvic abdominal metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, etc.; patients with peritoneal metastasis in the small bowel mesentery (regions 9-12) must be excluded.
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months before enrollment.
- Other untreated or concurrent tumors, except for cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients may be enrolled if the tumor was cured and there has been no evidence of disease for more than 5 years. All other tumors must have been treated at least 5 years before 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 |
|---|---|---|
| Tislelizumab+SOXOX: S-1 dosing 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 6 cycles. Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes. | Drug | – |
Primary outcome
Conversion surgery rate
Time frame: 1 year
Conversion surgery rate (the proportion of enrolled patients achieving R0 resection after treatment) for gastric cancer patients with peritoneal metastasis treated with Tislelizumab combined with HIPEC
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 12 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer with Peritoneal Metastasis, run by Southwest Hospital, 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (+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?
Conversion surgery rate (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 12 Nov 2024.