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

Sponsor
Fujian Medical University
Study ID
NCT06235164
Status
Unknown

Conditions

  • Locally Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Jan 1, 2019
Status verified
Jan 2024
Primary completion
Dec 30, 2022
Completion
Dec 30, 2025

Study Design

Enrollment
585 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

pathological complete response [ Time Frame: 4 months ]