Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital

About this trial

This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age >=18 years and <100 years.

2. Diagnosed with locally advanced gastric cancer.

3. Eastern Cooperative Oncology Group ECOG PS score 0-1.

4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.

Disqualifiers

1. Locally advanced unable to resect or metastatic tumors.

2. Patients with recurrence of residual gastric cancer

3. Patients refusing surgical resection after preoperative chemotherapy therapy.

4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SOX+Sintilimab

    Drug

    Patients would be allocated to the SOX+Sintilimab group.

  • FLOT+Sintilimab

    Drug

    Patients would be allocated to the FLOT+Sintilimab group.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: FLOT+SintilimabActive comparator 1 intervention
Group B: SOX+SintilimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rate of radical (R0) resection after neoadjuvant therapy

efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.

Time frame
From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days

Secondary outcomes

1

adverse event

adverse event caused by FLOT, SOX or Sintilimab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events

Time frame
From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
2

disease-free survival

from diagnosis to recurrence or death

Time frame
From date of diagnosis until the first documented recurrence or death, assessed up to 60 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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