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Observational Study on Hyperthermic Intraperitoneal Chemotherapy Combined with Investigator-Selected Systemic Treatment in Patients with Digestive System Tumors Accompanied by Peritoneal Metastasis or Ascites

Observational Study on Hyperthermic Intraperitoneal Chemotherapy Combined with Investigator-Selected Systemic Treatment in Patients with Digestive System Tumors Accompanied by Peritoneal Metastasis or Ascites

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115022
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-30
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

patients with digestive system tumors accompanied by peritoneal metastasis or ascites

Interventions

HIPEC:None

Sponsors

zhejiang hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Pathologically diagnosed with gastrointestinal malignant tumor (except for liver malignancies, which may be clinically diagnosed); 2.Complete and reliable medical history and records; 3.Present with radiologically confirmed peritoneal metastasis or ascites; 4.Essentially normal laboratory results and examinations, including blood count, liver and kidney function, and electrocardiogram: Neutrophil count >= 1.5×10^?/L; Platelets >= 80×10^?/L; Hemoglobin >= 9.0 g/dL; Total bilirubin 50% at screening; 5.ECOG score 0–3, age >= 18 and <90 years, and able to undergo ascites/pleural fluid puncture and peripheral blood sampling; 6.Good compliance and willingness to undergo regular follow-up.

Exclusion criteria

Exclusion criteria: 1.Concurrent severe comorbidities: Active tuberculosis or severe infectious diseases; autoimmune or rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus); severe cardiac, pulmonary, hepatic, or renal insufficiency, or major cardiovascular diseases. 2.Non-malignant causes of pleural effusion/ascites: Including fluid accumulation due to heart failure, nephrotic syndrome, or cirrhosis. 3.?Pregnancy or lactation: Excluded due to potential effects of pregnancy on immune dynamics and biomarker fluctuations. 4.Prior antitumor therapy: Patients who deviated from standard regimens or received other experimental treatments, which may confound immune response assessments. 5.Contraindications/allergies: Hypersensitivity to procedures or agents used in the study. 6.?Psychiatric disorders: Severe mental illness or inability to comply with study requirements. 7.Other exclusions: Any condition deemed by investigators to compromise study integrity or patient safety.

Design outcomes

Secondary

MeasureTime frame
Objective response rate,ORR;Progress Free Survival,PFS;Overall Survival, OS;

Primary

MeasureTime frame
DCR;

Countries

China

Contacts

Public ContactZhibing Wu

zhejiang hospital

wu_zhibing@163.com+86 138 5806 5026

Outcome results

None listed

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