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A single-center randomized controlled study of Intraperitoneal hyperthermic chemoperfusion in combination of Recombinant Human Tumor Necrosis Factor (TNF) in treatment of malignant ascites caused by advanced abdominal cancers.

A single-center randomized controlled study of Intraperitoneal hyperthermic chemoperfusion in combination of Recombinant Human Tumor Necrosis Factor (TNF) in treatment of malignant ascites caused by advanced abdominal cancers.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045155
Enrollment
Unknown
Registered
2021-04-07
Start date
2021-04-07
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Peritoneal metastasis of carcinoma

Interventions

Treatment group 2:When the chemotherapy medicines cause leukopenia or thrombocytopenia, Hematopoietic Stimulating Factors (HSF) can be given as a supportive treatment
Treatment group 3:When the subject is vomiting due to the chemotherapy, anti-emetic agents can be given.

Sponsors

Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Pathologically or cytologically confirmed pectoral or ventral or pelvic malignancy, positive peritoneal metastasis of these cancer or positive exfoliated cells of these cancer were detected in peritoneal lavage fluid; 2.Moderate or greater amount of pleural and peritoneal effusion.Definition of moderate ascites, ultrasonic examination of ascites in decubitus position (>= 3cm) ultrasound examination of pleural effusion in sitting position (>= 4cm) accompanied with clinical symptoms (Chest tightness, shortness of breath, abdominal distension and discomfort); 3.Age 18-75 years old; 4.Male or non-pregnant or lactating women; 5.Bone marrow reserve function is good, blood routine meets the following conditions: white blood cell (>3.5 *10^9/L), neutrophil (>1.5 *10^9/L), platelet(>100 *10^9/L), hemoglobin (>90 g/L); 6.Good organ function, biochemical examination met the following conditions: ALT < 2.5 * ULN, AST < 2.5 * ULN, serum total bilirubin < 1.5 * ULN, serum creatinine < 1.5 * ULN; 7.ECOG <= 1; 8.Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1.Drug allergy history of TNF and its derivatives; 2.Pregnant or lactating women, women of child-bearing age who were not willing to use contraception during the study periodOr men are unwilling to use effective contraceptives during treatment and for the next year; 3.Patients with severe or uncontrolled medical diseases and infections (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, uncontrollable hypertension, body temperature > 38 degrees C, etc.); 4.Encapsulated pleural effusion; 5.Severe hypoproteinemia; 6.HIV positive and active hepatitis; 7.Patients who need to be treated for epileptic seizures (e.g. steroids or antiepileptic therapy; 8.Patients with severe or uncontrollable mental illness; 9.Drug abuse and medical, psychological or social conditions may interfere with patients'participation in research or influence the evaluation of research results; 10.Any unstable conditions or situations that may endanger the safety and compliance of patients; 11.Receiving anticancer drugs from other clinical trials; 12.Researchers believe that patients should not participate in other situations of the trial.

Design outcomes

Primary

MeasureTime frame
Drainage volume;Extubation time of drainage tube;Length of stays;Postoperative complications (adhesions, abdominal pain, fever, chills, etc.);

Countries

China

Contacts

Public ContactZhang Huatang, Meng Jincheng

Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine

18938799001@189.cn+86 18938799001

Outcome results

None listed

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