Randomized controlled study of rmhTNF versus paclitaxel intraperitoneal perfusion in the treatment of peritoneal metastasis of gastric cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083006

Enrollment

Unknown

Registered

2024-04-12

Start date

2022-09-28

Completion date

Unknown

Last updated

2024-04-15

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:Intraperitoneal infusion of rmhTNF 15 million/time on the 1st and 3rd day after surgery

B:Intraperitoneal infusion of paclitaxel injection on the 1st and 3rd day after surgery

C:On the 1st and 3rd day after surgery, intraperitoneal infusion of rmhTNF 15 million/dose and paclitaxel injection was administered

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) ECOG <= 1; (5) 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

Measure	Time frame
1-year overall survival rate;	—

Secondary

Measure	Time frame
Progression free survival rate;	—

Countries

China

Contacts

Public ContactPeng Chunwei

Zhongnan Hospital of Wuhan University

whupengcw@whu.edu.cn+86 134 7619 6566

Outcome results

None listed

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