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Photodynamic therapy in combination with immune checkpoint inhibitors plus chemotherapy for first-line treatment in advanced or metastatic gastric or gastroesophageal junction cancer: a phase 2-3 clinical trial

Clinical application of photodynamic therapy in digestive tract tumor

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064280
Enrollment
Unknown
Registered
2022-10-01
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

untreated gastric or gastroesophageal junction adenocarcinoma

Interventions

Test group:PDT+ICI+chemotherapy
Control group:ICI+chemotherapy

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients who meet the following criteria will be enrolled: 1. 18-65 years old; 2. untreated gastric or gastroesophageal junction adenocarcinoma confirmed by histopathological examination; 3. advanced or metastatic stage; 4. ECOG score 0-2; 5. expected survival >6 months; 6. having at least one measurable lesion; 7. adequate bone marrow, kidney and liver function defined as neutrophil count>= 1.5×10^9/L, platelet count >=100×10^9/L, creatinine<= 1.5 times the upper limit of normal (ULN), total bilirubin<= 1.5 times the ULN, and aspartate transaminase and alanine aminotransferase <= 5.0 times the ULN; 8. and providing a signed informed consent.

Exclusion criteria

Exclusion criteria: Any participants will be excluded when they have one of the following conditions: 1. multiple primary tumors; 2. prior usage of immunomodulator drugs or any medicines having an direct impacts on the immune system; 3. pregnancy or lactation for women; 4. history of allergy to the tested medications or light sensitiveness; 5. contraindication to gastroscopy; 6. comorbidities including autoimmune disease, severe cardiovascular disease, mental illness or severe neurosis, gastrointestinal bleeding and other sever diseases; 7. other inappropriate condition for inclusion determined by the researchers.

Design outcomes

Primary

MeasureTime frame
ORR;PFS;

Secondary

MeasureTime frame
Incidence of adverse events;

Countries

China

Contacts

Public ContactHao Chen

Lanzhou University Second Hospital

ery_chenh@lzu.edu.cn+86 15009467790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026