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First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

ConditionsAdvanced Gastric CancerLocally Advanced Gastric Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorQilu Hospital of Shandong University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: ICI plus chemotherapy1 intervention
Group B: Chemotherapy1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

The time from the starting date of study drug to death

Time frame
12 months after the last subject participating in

Secondary outcomes

1

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

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

Time frame
6 months after the last subject participating in
2

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

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.

Time frame
12 months after the last subject participating in
3

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

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).

Time frame
12 months after the last subject participating in
4

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

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

Time frame
12 months after the last subject participating in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov
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