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To evaluate the safety and effectiveness of laparoscopic gastrectomy (LG) following neoadjuvant immunochemotherapy (nICT)
comparing the radiological response, pathological response rate, perioperative outcomes, and early recurrence between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant immunochemotherapy group | 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. |
| |
| neoadjuvant chemotherapy group | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab | Drug | Drug: Sintilimab, Nivolumab, and Camrelizumab,One course will last 21 days.Given once every 3 weeks at a dose of 200 mg. Drug: nab-paclitaxel nab-paclitaxel one course will last 21 days#Given twice every 3 weeks at a dose of 125 mg/m2. Drug:oxaliplatin Oxaliplatin one course will last 21 days#Given once every 3 weeks at a dose of 130 mg/m2. Drug:docetaxel docetaxel one course will last 21 days#Given once every 3 weeks at a dose of 40mg/m2. Drug:fluorouracil fluorouracil one course will last 14 days#Given once every 2 weeks at a dose of 2800mg/m2. Drug: Capecitabine Capecitabine was calculated according to body surface area every 3 weeks at a dose of 1000 mg/m2, P.O., bid, d1-d14 Drug: S1 S-1 was calculated according to body surface area, P.O., bid, d1-d14#And the dosage according body surface area:<1.25m2, 40mg everytime;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response | pathological complete response (pCR) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| major pathological response | major pathological response#MPR | 4 months |
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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#
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:
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patients with locally advanced gastric cancer who underwent neoadjuvant therapy
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Ming Huang | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |