Status:
NOT_YET_RECRUITING
HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
Lead Sponsor:
Sichuan University
Conditions:
Peritoneal Metastases
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 treatmen...
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 receiv...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06213519
Start Date
February 20 2024
End Date
June 30 2027
Last Update
January 19 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.