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Clinical Study of Camrelizumab, Apatinib Mesylate and Nab-paclitaxel Combined With Oxplatin and S-1 in the Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes

ConditionLocally Advanced Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 75 years, all sex；

Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology；

CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.；

measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of lymph node≥15mm，scan slice thickness 5mm）;

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.

  • Oxaliplatin

    Drug

    Oxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks.

  • S1

    Drug

    S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time

  • Apatinib Mesylate

    Drug

    Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.

  • Nab paclitaxel

    Drug

    nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8.

Treatment groups

203 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Camrelizumab combined with Oxplatin and S-1 for Immune GenotypesExperimental treatment 3 interventions
Group B: Oxplatin and S-1 for Immune GenotypesActive comparator 2 interventions
Group C: Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal GenotypesExperimental treatment 3 interventions
Group D: Oxplatin and S-1 for Mesenchymal GenotypesActive comparator 2 interventions
Group E: Nab-paclitaxel combined with Oxplatin and S-1 for Classic GenotypesExperimental treatment 3 interventions
Group F: Oxplatin and S-1 for Classic GenotypesActive comparator 2 interventions
Group G: Oxplatin and S-1 for Metabolic GenotypesActive comparator 2 interventions

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

Time frame
4 months
3

1-year and 3-year OS/DFS

Time frame
1 and 3 years
4

adverse event

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Time frame
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: