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NCT Number: NCT06727981

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

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

Recruiting

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Key information

Conditions

Advanced Gastric Cancer Locally Advanced Gastric Carcinoma

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with contraindications to immunotherapy
  • Have received anti-tumor treatments such as immunotherapy and chemotherapy
  • 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
  • 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
  • History of allogeneic stem cell transplantation or organ transplantation

Treatment and study plan

ICI plus Chemothearpy

Drug

This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.

Chemotherapy

Drug

This intervention involves the administration of standard chemotherapy alone.

Primary outcomes

  1. Overall survival (OS)

    Time frame: 12 months after the last subject participating in

    The time from the starting date of study drug to death

Secondary outcomes

  1. Disease Control Rate (DCR) as assessed by RECIST1.1

    Time frame: 6 months after the last subject participating in

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects.

  2. Duration of response (DOR) as assessed by RECIST1.1

    Time frame: 12 months after the last subject participating in

    The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

  3. Number of participants with treatment-related adverse events as assessed by CTCAE5.0

    Time frame: 12 months after the last subject participating in

    Incidence and severity of adverse effects associated with the treatments, categorized by type and grade according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

  4. Progression-free survival (PFS) as assessed by RECIST1.1

    Time frame: 12 months after the last subject participating in

    The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first

  5. Objective remission rate (ORR) as assessed by RECIST1.1

    Time frame: 3 months after the last subject participating in

    The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

  6. Disease-free survival (DFS) as assessed by RECIST1.1

    Time frame: 36 months after the last subject participating in

    The period from treatment until the occurrence of disease recurrence, progression, or death.

  7. Major pathological response (MPR)

    Time frame: 3 months after the last subject participating in

    he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Lian Liu, MD

CONTACT

[email protected]

0531-82169851

Song Li, MD

CONTACT

0531-82169851

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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