Peritoneal MetastasesPhase 2NCT06213519
HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
A Phase 2 study testing S-1, Oxaliplatin sintilimab HIPEC in people with Peritoneal Metastases and Gastric Cancer, run by Sichuan University.
Trial summary
The prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Metastases, Gastric Cancer
- What is being tested?
- S-1, Oxaliplatin sintilimab HIPEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 30 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological or cytological examination;
- No previous antitumor treatment.
- Agree to provide blood/tissue specimens.
- The expected survival is more than 3 months.
- ECOG PS≤1.
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- Adequate organ function including the following:
- Total bilirubin ≤1.5 times the upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
- Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
- Serum creatinine≤1.5×ULN;
- Serum amylase and lipase≤1.5×ULN;
- International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
- Platelet count ≥ 75,000 /mm3;
- Hemoglobin (Hb) ≥ 9 g/dL;
- Absolute neutrophil count (ANC) ≥ 1500/mm3;
- Strict contraception.
- Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Who cannot join
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroids (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA) class 2;
- Active coronary artery disease;
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- Arrhythmias requiring treatment other than β-blockers or digoxin;
- Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6 months prior to enrollment;
- Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
- Patients with pheochromocytoma.
- Patients with a history of HIV infection or active hepatitis B/C.
- Ongoing > level 2 infection.
- Symptomatic brain metastasis or meningioma.
- Unhealed wounds, ulcers or fractures.
- Renal failure patients requiring blood or peritoneal dialysis.
- Epileptic that needs medication.
- History of organ transplantation (including corneal transplantation).
- Allergic to research drugs or similar drugs, or suspected allergies.
- Pregnant or lactating women.
- Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results.
- Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
- Previously used similar chemotherapy drugs or immune checkpoint inhibitors;
- Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage).
- Treatment with antitumor Chinese herbal medicine.
- Vaccination history 4 weeks prior to enrollment
- The investigator believes that patients who are not suitable for the study.
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
Official title: The Efficacy and Safety of Hyperthermic Intraperitoneal Chemotherapy （HIPEC）Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis: A Prospective, Single-arm, Phase II Clinical Study
The prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Hyperthermic intraperitoneal chemotherapy (HIPEC) represents a novel treatment option, which maintains the high concentration of drugs in the abdominal cavity, and improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma with peritoneal metastasis.
Read the detailed description
To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer with peritoneal metastasis, patients will receive SOX regimen chemotherapy combined with sintilimab, once every three weeks. In the first cycle, HIPEC will be administrated, and HIPEC or intraperitoneal chemotherapy will be administrated in the second to third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy will be administrated. After the end of 6 cycles, patients will receive maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.
- Conditions
- Peritoneal Metastases, Gastric Cancer
- Being tested
- S-1, Oxaliplatin sintilimab HIPEC
- Keywords
- gastric cancer, peritoneal metastasis, HIPEC, first-line
- 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-1, Oxaliplatin sintilimab HIPECDrug
- Exploratory laparoscopy or laparotomy
- SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA < 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks.
- In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated,
- In the second and third cycles, HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated according to the patient's condition.
- Another 3-cycle SOX regimen of systemic chemotherapy.
- After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| SOX+sintilimab+HIPEC | Experimental | Patient will receive SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA < 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, and HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated in the second and third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity. Receives: Drug: S-1, Oxaliplatin sintilimab HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) is defined as the time from randomization to death
Measured: every 3 month postoperation up to 24 months
Secondary outcomes (4)
ORR
Objective Response Rate
Measured: every 3 month postoperation up to 24 months
DCR
disease control rate
Measured: every 3 month postoperation up to 24 months
Progression-free survival
Progression-free survival (PFS) is defined as the time from randomization to diesea progression
Measured: every 3 month postoperation up to 24 months
Safety and Tolerability
Treatment-related adverse events as assessed by CTCAE v4.0
Measured: every 3 month postoperation up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start20 Feb 2024 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies of the same condition, open and under way.
- More trials run by Sichuan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Zhang, MD, Sichuan University
- Investigators
- Kun Yang, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213519
- Sponsor's protocol ID
- WCH-2023-1784
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 19 Jan 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Hyperthermic Intraperitoneal Chemotherapy （HIPEC）Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis: A Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06213519
- Acronym / sponsor ID
- WCH-2023-1784
- Conditions
- Peritoneal Metastases, Gastric Cancer
- Keywords
- gastric cancer, peritoneal metastasis, HIPEC, first-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Jan 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 prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Hyperthermic intraperitoneal chemotherapy (HIPEC) represents a novel treatment option, which maintains the high concentration of drugs in the abdominal cavity, and improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma with peritoneal metastasis.
Detailed description
To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer with peritoneal metastasis, patients will receive SOX regimen chemotherapy combined with sintilimab, once every three weeks. In the first cycle, HIPEC will be administrated, and HIPEC or intraperitoneal chemotherapy will be administrated in the second to third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy will be administrated. After the end of 6 cycles, patients will receive maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX+sintilimab+HIPEC | Experimental | Drug: S-1, Oxaliplatin sintilimab HIPECPatient will receive SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA < 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, and HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated in the second and third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 18-75 years.
- Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological or cytological examination;
- No previous antitumor treatment.
- Agree to provide blood/tissue specimens.
- The expected survival is more than 3 months.
Key exclusion criteria (27 listed)
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroids (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 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 |
|---|---|---|
| S-1, Oxaliplatin sintilimab HIPEC1. Exploratory laparoscopy or laparotomy 2. SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA < 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. 3. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, 4. In the second and third cycles, HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated according to the patient's condition. 5. Another 3-cycle SOX regimen of systemic chemotherapy. 6. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity. | Drug | SOX+sintilimab+HIPEC |
Primary outcome
Overall survival
Time frame: every 3 month postoperation up to 24 months
Overall survival (OS) is defined as the time from randomization to death
4 secondary outcomes
ORR
Time frame: every 3 month postoperation up to 24 months
DCR
Time frame: every 3 month postoperation up to 24 months
Progression-free survival
Time frame: every 3 month postoperation up to 24 months
Safety and Tolerability
Time frame: every 3 month postoperation up to 24 months
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 19 Jan 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.
Kun Yang, M.D. principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, Oxaliplatin sintilimab HIPEC in people with Peritoneal Metastases and Gastric Cancer, run by Sichuan University.
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 18 inclusion and 27 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 19 Jan 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.
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?
Contact Hongfeng Gou, M.D (+8618980602292, gouhongfeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: every 3 month postoperation up to 24 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 19 Jan 2024.