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Trial Title:
HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
NCT ID:
NCT06213519
Condition:
Peritoneal Metastases
Gastric Cancer
Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms
Oxaliplatin
Conditions: Keywords:
gastric cancer
peritoneal metastasis
HIPEC
first-line
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1, Oxaliplatin sintilimab HIPEC
Description:
1. 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.
Arm group label:
SOX+sintilimab+HIPEC
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with
peritoneal metastasis through laparoscopic exploration and pathological or
cytological examination;
3. No previous antitumor treatment.
4. Agree to provide blood/tissue specimens.
5. The expected survival is more than 3 months.
6. ECOG PS≤1.
7. Adequate organ function including the following:
1. Total bilirubin ≤1.5 times the upper limit of normal (ULN);
2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
3. Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
4. Serum creatinine≤1.5×ULN;
5. Serum amylase and lipase≤1.5×ULN;
6. International standardized ratio (INR)/partial thromboplastin time
(PTT)≤1.5×ULN;
7. Platelet count ≥ 75,000 /mm3;
8. Hemoglobin (Hb) ≥ 9 g/dL;
9. Absolute neutrophil count (ANC) ≥ 1500/mm3;
8. Strict contraception.
9. 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.
Exclusion Criteria:
1. Undergoing other drug clinical trials or having participated in any drug clinical
trials one month before enrollment.
2. Active autoimmune disease or history of refractory autoimmune disease.
3. 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.
4. Active or clinically significant cardiac disease:
1. Congestive heart failure > New York Heart Association (NYHA) class 2;
2. Active coronary artery disease;
3. Arrhythmias requiring treatment other than β-blockers or digoxin;
4. Unstable angina (with angina symptoms at rest), new angina within 3 months
before enrollment, or new myocardial infarction within 6 months before
enrollment
5. Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6
months prior to enrollment;
6. 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.
7. Patients with pheochromocytoma.
8. Patients with a history of HIV infection or active hepatitis B/C.
9. Ongoing > level 2 infection.
10. Symptomatic brain metastasis or meningioma.
11. Unhealed wounds, ulcers or fractures.
12. Renal failure patients requiring blood or peritoneal dialysis.
13. Epileptic that needs medication.
14. History of organ transplantation (including corneal transplantation).
15. Allergic to research drugs or similar drugs, or suspected allergies.
16. Pregnant or lactating women.
17. Medical, psychological or social conditions can affect the recruitment of patients
and evaluation of study results.
18. Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy,
biotherapy, chemoembolization) other than investigator drugs. Palliative external
irradiation for non-target lesions is allowed.
19. Previously used similar chemotherapy drugs or immune checkpoint inhibitors;
20. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery
(excluding biliary stents, or percutaneous biliary drainage).
21. Treatment with antitumor Chinese herbal medicine.
22. Vaccination history 4 weeks prior to enrollment
23. The investigator believes that patients who are not suitable for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
February 20, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06213519
