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Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1

Study acronym: TACTIC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Apr 1, 2023 to Mar 1, 2023v6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date changed from estimate of May 2023 to Apr 1, 2023v4
  4. Eligibility criteria expanded, about 43 wordsv3 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 360 to 190 · Start date: Jan 2023 to May 2023 · Primary endpoint revised · 4 morev2 Show 7 more changesShow less
    • Enrollment target: 360 to 190
    • Start date: Jan 2023 to May 2023
    • Primary endpoint revised
    • Interventions: Oxaliplatin by arterial infusion plus S-1 (Drug), SOX adjuvant, Sequential S-1 (Drug), SOX neoadjuvant (Drug), gastrectomy plus D2 lymph… to Oxaliplatin by arterial infusion plus S-1 (Drug), SOX adjuvant, Sequential S-1 (Drug), SOX neoadjuvant (Drug), Sintilimab adjuvant (Drug)…
    • Secondary endpoints: 2 to 4
    • Site details revised
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer. Participants will be randomised, and receive: * 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy; * Adequate gastric resection along with D2 lymph node dissection; * 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody. * Administration of S-1 regularly till 1 year after surgery. Researchers will compare Major pathological response rate (MPR) ，pathologic complete response rate（pCR）,the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.
Trial Details
NCT Number NCT05593458
Lead Sponsor Zhejiang University
Conditions Locally Advanced Gastric Carcinoma
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov