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Prospective Study With HIPEC and AS regimen plus PD-1 antibody in Patients With Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Prospective Study With HIPEC and AS regimen plus PD-1 antibody in Patients With Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060817
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenocarcinoma of Stomach or Esophagogastric Junction

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 11.Aged 18-70 years; 2.The primary gastric lesion is diagnosed as gastric or esophageal gastric junction adenocarcinoma by gastroscopy biopsy (papillary adenocarcinoma, pap; tubular adenocarcinoma, tub; mucinous adenocarcinoma, muc; signet ring cell carcinoma, sig; poorly differentiated 3.adenocarcinoma, por) 4.The tumor is located in the stomach or esophagogastric junction (Siewert type II/III) 5.The preoperative clinical staging is cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis) 6.Good bone marrow reserve: HB>= 90g/L; ANC>= 1.5×10^9/L; PLT>= 80×10^9/L 7.Good liver and kidney function reserve: BIL<=1.5 times the upper limit of normal(ULN); ALT and AST<=2.5×ULN; Crea<=1×ULN; 8.Good coagulation function: International Normalized Ratio (INR) or Prothrombin Time(PT)<=1.5 times ULN, activated partial thromboplastin time (APTT)<=1.5 times ULN 9.Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 10.No previous chemotherapy, radiotherapy, targeted therapy and immunotherapy; 11.Informed consent of patients.

Exclusion criteria

Exclusion criteria: 1.There are distant metastases other than peritoneal metastases; 2.Complications of gastric cancer requiring emergency treatment, such as bleeding, perforation and obstruction; 3.Suffer from other malignant tumors within five years; 4.Body temperature >= 38? or complicated with infectious diseases requiring systemic treatment; 5.For those with a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications; 6.Clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months; 7.Severe respiratory diseases; 8.Severe liver and kidney dysfunction; 9.Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs; 10.Diseases such as severe diabetes, hyperthyroidism and hypothyroidism that have not been clinically controlled. 11.Those who continued to use glucocorticoid therapy within 1 month (except for local use) or need immunosuppressive therapy for organ transplantation; 12.Pregnant or lactating women; 13.The patient has participated or is participating in other clinical studies (within 6 months).

Design outcomes

Primary

MeasureTime frame
The rate of OS at three years;

Secondary

MeasureTime frame
The rate of PFS at 3-year;

Countries

China

Contacts

Public ContactCui Yuehong

Zhongshan Hospital

cui.yuehong@zs-hospital.sh.cn+8613916912156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026