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

NCT05610332 | Not Yet Recruiting Phase 3

• 1 other identifier: Arise-FJ-G007
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

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

  4 months

Secondary Outcomes (9)

• R0 resection rate

  4 months

• Disease control rate

  4 months

• 1-year and 3-year OS

  1 and 3 years

• 1-year and 3-year DFS

  1 and 3 years

• Adverse event

  3 years

Study Arms (4)

Immune activated experimental group

EXPERIMENTAL

Albumin paclitaxel 260mg/m2, ivgtt, d1, d8 Carrelizumab: 200mg, ivgtt, d1, q3w

Drug: Camrelizumab; Drug: Albumin Taxol

Immune activated control group

ACTIVE COMPARATOR

Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d

Drug: FLOT scheme

Immune silence experimental group

EXPERIMENTAL

Carrelizumab: 200mg, ivgtt, d1, q3w Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d

Drug: Camrelizumab; Drug: FLOT scheme

Immunosilent control group

ACTIVE COMPARATOR

Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d

Drug: FLOT scheme

Interventions

Camrelizumab DRUG

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

Immune activated experimental group; Immune silence experimental group

Albumin Taxol DRUG

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

Immune activated experimental group

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

Immune activated control group; Immune silence experimental group; Immunosilent control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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，
• PLT≥100×109/L；
• biochemical examination shall comply with the following criteria：
• BIL \<1.5normal upper limit（ULN），
• ALT和AST\<2.5ULN，GPT≤1.5×ULN；
• 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.

You may not qualify if:

• 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；
• 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；
• Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection；
• Pregnant or lactating women；
• 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)；
• With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male \> 450 ms, women \> 470 ms) and cardiac insufficiency；
• 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;；
• 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；
• History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia；
• Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative \>1.0g)；

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (2)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

camrelizumab

Study Officials

• Chang-Ming Huang, Ph.D.

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Ming Huang, Ph.D.

CONTACT

8613805069676; hcmlr2002@163.com

Hua-long Zheng, Ph.D.

CONTACT

18359190587; 291167038@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of gastric surgery

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: November 9, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

CN (2)