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Clinical Efficacy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes

ConditionLocally Advanced Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

To evaluate the clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

blood routine examination standards should be met（no blood transfusion within 14 days）

HB≥100g/L，

WBC≥3×109/L

ANC≥1.5×109/L，

Disqualifiers

Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy

Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery；

Patients with metastasis；

Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Camrelizumab

    Drug

    Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.

  • Albumin Taxol

    Drug

    Albumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle

  • FLOT scheme

    Drug

    Docetaxel 50mg/m2, ivgtt, d1; Oxaliplatin 85 mg/m2, ivgtt, d1; Calcium folinate 200mg/m2, ivgtt, d1; 5-fluorouracil 2600mg/m2, 24h civ, d1, 4 cycles before and after operation, q2w

Treatment groups

216 Participants
are divided into 4 treatment groups
Group A: Immune activated experimental groupExperimental treatment 2 interventions
Group B: Immune activated control groupActive comparator 1 intervention
Group C: Immune silence experimental groupExperimental treatment 2 interventions
Group D: Immunosilent control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Time frame
4 months

Secondary outcomes

1

R0 resection rate

The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy

Time frame
4 months
2

Disease control rate

Disease control rate

Time frame
4 months
3

1-year and 3-year OS

1-year and 3-year OS

Time frame
1 and 3 years
4

1-year and 3-year DFS

1-year and 3-year DFS

Time frame
1 and 3 years

Other outcomes

Sponsors and contacts

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

Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: