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

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

NCT ID: NCT05610332

Condition: Locally Advanced Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab
Description: Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
Arm group label: Immune activated experimental group
Arm group label: Immune silence experimental group

Intervention type: Drug
Intervention name: Albumin Taxol
Description: Albumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle
Arm group label: Immune activated experimental group

Intervention type: Drug
Intervention name: FLOT scheme
Description: 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
Arm group label: Immune activated control group
Arm group label: Immune silence experimental group
Arm group label: Immunosilent control group

Summary: 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

Detailed description: Background: At present, there is still a lack of prospective data to systematically compare the clinical efficacy of different neoadjuvant therapies in patients with different genotypes. To explore the clinical efficacy and safety of albumin paclitaxel combined with carrelizumab compared with FLOT neoadjuvant therapy in patients with locally advanced gastric cancer of different immune types. Methods: This study is a multi center prospective study. 216 patients with gastric adenocarcinoma were included in the study to explore the proportion of PD-L1 positive cells in tumor tissue, evaluate the expression of PD-L1, serum HBV DNA level or other biomarkers.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age from 18 to 75 years, all sex； 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology； 3. 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.； 4. 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）; 5. ECOG(Eastern Cooperative Oncology Group) PS(Performance Status):0-1 scores; 6. The expected survival time is more than 12 weeks; 7. The main organ function is normal, which should meet the following criteria: 1. blood routine examination standards should be met（no blood transfusion within 14 days） 1. HB≥100g/L， 2. WBC≥3×109/L 3. ANC≥1.5×109/L， 4. PLT≥100×109/L； 2. biochemical examination shall comply with the following criteria： 1. BIL <1.5normal upper limit（ULN）， 2. ALT和AST<2.5ULN，GPT≤1.5×ULN； 3. serum Cr≤1ULN，creatinine clearance rate>60ml/min（Cockcroft-Gault formula） 8. women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug.； 9. No other clinical studies were conducted before and during the treatment； participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up. Exclusion Criteria: 1. Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy 2. Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery； 3. Patients with metastasis； 4. 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； 5. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation； 6. Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection； 7. Pregnant or lactating women； 8. The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)； 9. With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male > 450 ms, women > 470 ms) and cardiac insufficiency； 10. Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;； 11. Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure or above (2) unstable angina pectoris (3) MI occurred within 1 year (4) have clinical significance of supraventricular or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled； 12. History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia； 13. Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g)； 14. A person who has previously been allergic to any component of the drug in this study； The researchers consider those who were not suitable for inclusion.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fujian Medical University Union Hospital

Address:
City: Fuzhou
Zip: 350000
Country: China

Facility:
Name: Department of Gastric Surgery

Address:
City: Fuzhou
Country: China

Start date: November 1, 2022

Completion date: November 1, 2027

Lead sponsor:
Agency: Fujian Medical University
Agency class: Other

Source: Fujian Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05610332