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Multicenter randomized controlled study for rmhTNF versus paclitaxel intraperitoneal infusion in the treatment of peritoneal metastasis of gastric cancer

Multicenter randomized controlled study for rmhTNF versus paclitaxel intraperitoneal infusion in the treatment of peritoneal metastasis of gastric cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023675
Enrollment
Unknown
Registered
2019-06-07
Start date
2019-06-15
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Peritoneal metastasis of gastric cancer

Interventions

A:Peritoneal exploration + rmhTNF intraperitoneal perfusion for 2 times + 6 cycles of systemic chemotherapy
B:Peritoneal exploration + paclitaxel intraperitoneal perfusion for 1 time + 6 cycles of systemic chemotherapy
C:Peritoneal exploration + rmhTNF intraperitoneal perfusion for 2 times + paclitaxel intraperitoneal perfusion for 1 time + systemic chemotherapy for 6 cycles

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Pathologically confirmed gastric adenocarcinoma, positive peritoneal metastasis of gastric cancer or positive exfoliated cells of gastric cancer were detected in peritoneal lavage fluid during peritoneal exploration. (2) Aged 18-75 years; (3) Male or non-pregnant or lactating women; (4) 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); (5) 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; (6) ECOG <= 1; (7) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Drug allergy history of TNF and its derivatives; (2) There is a history of other malignant tumors within 5 years. (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 C, etc.); (4) Patients who need to be treated for epileptic seizures (e.g. steroids or antiepileptic therapy); (5) Patients with severe or uncontrollable mental illness; (6) Drug abuse and medical, psychological or social conditions may interfere with patients'participation in research or influence the evaluation of research results; (7) Any unstable condition or situation that may endanger patient's safety and compliance; (8) Receiving anticancer drugs from other clinical trials; (9) Researchers believe that patients should not participate in other situations of the trial.

Design outcomes

Primary

MeasureTime frame
1 years OS;

Countries

China

Contacts

Public ContactWu Xiaojiang

Beijing Cancer Hospital

drwuxiaojiang@163.com+86 13810197049

Outcome results

None listed

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