Clinical trial NCT06727981: First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
Official title: Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Gastric Cancer
Locally Advanced Gastric Carcinoma
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pathologically defined, locally inoperable or advanced gastric cancer who have not received any previous anti-tumor therapy and are expected to receive immunotherapy.

Brief summary: This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes


Eligibility criteria: Inclusion Criteria:

1. Age 18 years old or above
2. Patients with advanced gastric cancer or locally advanced gastric cancer
3. Have not received any previous anti-tumor therapy
4. Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Adequate organ function

Exclusion Criteria:

1. Patients with contraindications to immunotherapy
2. Have received anti-tumor treatments such as immunotherapy and chemotherapy
3. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
4. Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
5. History of allogeneic stem cell transplantation or organ transplantation

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 12 months after the last subject participating in
Secondary outcomes:
measure: Disease Control Rate (DCR) as assessed by RECIST1.1
timeFrame: 6 months after the last subject participating in
measure: Duration of response (DOR) as assessed by RECIST1.1
timeFrame: 12 months after the last subject participating in
measure: Number of participants with treatment-related adverse events as assessed by CTCAE5.0
timeFrame: 12 months after the last subject participating in
measure: Progression-free survival (PFS) as assessed by RECIST1.1
timeFrame: 12 months after the last subject participating in
measure: Objective remission rate (ORR) as assessed by RECIST1.1
timeFrame: 3 months after the last subject participating in
measure: Disease-free survival (DFS) as assessed by RECIST1.1
timeFrame: 36 months after the last subject participating in
measure: Major pathological response (MPR)
timeFrame: 3 months after the last subject participating in
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Lian Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: