The Safety and Efficacy of Neoadjuvant Immunochemotherapy Followed by Laparoscopic Gastrectomy for Gastric Cancer

Fujian Medical University

Status: Active, not recruiting

Conditions: Locally Advanced Gastric Cancer

Treatments: Drug: immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06235164

2023KY160

Details and patient eligibility

About

To evaluate the safety and effectiveness of laparoscopic gastrectomy (LG) following neoadjuvant immunochemotherapy (nICT)

Full description

comparing the radiological response, pathological response rate, perioperative outcomes, and early recurrence between the two groups.

Enrollment: 585 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-85 years of age

• Gastric adenocarcinoma was confirmed by pathology# including 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≥15mm#scan slice thicknes 5mm#

• ECOG#Eastern Cooperative Oncology Group#PS#Performance Status#:0-1 scores;

• the expected survival time is more than 12 weeks

• 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#

  a#HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L #2#biochemical examination shall comply with the following criteria#

  1. BIL#1.5 normal upper limit ULN
  2. ALT and AST#2.5 ULN,GPT≤1.5×ULN
  3. Cr≤1 ULN#CCR#creatinine clearance rate#60ml/min(Cockcroft Gault formula)

• 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 test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test#

• 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

• 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 larger 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 # 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 unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage#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 (2) above unstable angina pectoris (3) occurred within 1 year (4) have clinical significance of myocardial infarction (mi) room sex 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);
• A person who has previously been allergic to any component of camrilizumab or to any component of the drug under study
• The researchers consider those who were not suitable for inclusion.

Trial design

585 participants in 2 patient groups

neoadjuvant immunochemotherapy group

Description:

The immune checkpoint inhibitors (ICIs) used for neoadjuvant immunotherapy in this study included sintilimab, nivolumab, and camrelizumab. Neoadjuvant chemotherapy regimens were primarily categorized into two- and three-agent regimens. The two-agent regimens included: SOX (S-1 + oxaliplatin), CapeOx (capecitabine + oxaliplatin), AS (S-1 + nab-paclitaxel), FOLFOX (oxaliplatin + fluorouracil) and DS (S-1 + docetaxel). The three-agent regimens included: FLOT (docetaxel + oxaliplatin + fluorouracil), DOS (docetaxel + oxaliplatin + S-1) and POF (paclitaxel + oxaliplatin + fluorouracil). Dosages were calculated based on drug monographs, guidelines, and patient body surface area. The patients underwent LG within 4-6 weeks after completing neoadjuvant therapy.

Treatment:

Drug: immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab

neoadjuvant chemotherapy group

Description:

Neoadjuvant chemotherapy regimens were primarily categorized into two- and three-agent regimens. The two-agent regimens included: SOX (S-1 + oxaliplatin), CapeOx (capecitabine + oxaliplatin), AS (S-1 + nab-paclitaxel), FOLFOX (oxaliplatin + fluorouracil) and DS (S-1 + docetaxel). The three-agent regimens included: FLOT (docetaxel + oxaliplatin + fluorouracil), DOS (docetaxel + oxaliplatin + S-1) and POF (paclitaxel + oxaliplatin + fluorouracil). Dosages were calculated based on drug monographs, guidelines, and patient body surface area. The patients underwent LG within 4-6 weeks after completing neoadjuvant therapy.