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Efficacy and safety of PDT combined with metal stent in the treatment of outflow tract obstruction in advanced gastric cancer

Efficacy and safety of PDT combined with metal stent in the treatment of outflow tract obstruction in advanced gastric cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075234
Enrollment
Unknown
Registered
2023-08-30
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Gastric cancer

Interventions

PDT+stent:NA
Stent:NA

Sponsors

Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed/or clinically confirmed advanced unresectable MGOO 2) Previously received or not received standard chemotherapy or targeted therapy or immunotherapy; 3) Age = 18 years old and no more than 75 years old; 4) Expected survival period = 3 months; 5) ECOG score 0-1; 6) There is at least one measurable tumor lesion: on spiral CT, the long diameter is = 10 mm, and the short diameter of lymph nodes is = 15 mm; in ordinary CT or physical examination, the maximum diameter must be = 20 mm; 7) No major organ failure 8) No severe coagulation dysfunction 9) Those who can tolerate electronic gastroscopy 10) Volunteer to join this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who are known to be allergic to photosensitizers and artificially synthesized monoclonal antibodies or immunosuppressants; 2) Patients who cannot tolerate local photodynamic surgery or electronic gastroscopy; 3) Patients who have previously received monoclonal antibody therapy and have irAEs of grade 2 or above; 4) Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of study treatment; 5) Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement After treatment can be included)); patients with complete remission of childhood asthma and no need for any intervention in adulthood or vitiligo can be included, but patients who require medical intervention with bronchodilators are not included; 6) Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (positive hepatitis C antibody, and high HCV-RNA lower limit of detection of the analytical method) or co-infection with hepatitis B and hepatitis C; 7) Patients with severe hepatic encephalopathy; 8) Obvious blood coagulation disorder, active bleeding and bleeding tendency; 9) There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ); 10) Patients with severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months) and patients who cannot tolerate tumor treatment drugs; 11) Severe infection (such as: requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration; 12) During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during this test; 13) The investigator believes that there is any condition that may harm the subject or cause the subject to be unable to meet or perform the research requirements.

Design outcomes

Primary

MeasureTime frame
GOOSS;Overall survival;KPS;objective response rate;disease control rate;progression-free survival;duration of remission;

Countries

China

Contacts

Public ContactHao Chen

Second Hospital of Lanzhou University

ery_chenh@lzu.edu.cn+86 150 0946 7790

Outcome results

None listed

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