Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04150640 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2027
    • Study completion pushed from Dec 2027 to May 2028
    • Eligibility criteria expanded, about 16 words
    v21
  2. Eligibility criteria shortened, about 3 wordsv20
  3. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    v19
  4. 4 versions Re-verified since Nov 14, 2022, no change to tracked fieldsv15-v18
  5. Enrollment target: 34 to 52v14 Show 9 more changesShow less
    • Primary completion date: Dec 2022 to Dec 2025
    • Primary endpoints: 2 to 3
    • Study completion date: Dec 2022 to Dec 2026
    • Interventions: 5-FU (Drug), Nal-IRI (Drug), Oxaliplatin (Drug), Trastuzumab (Drug) to 5-FU (Drug), Nal-IRI (Drug), Nivolumab (Drug), Oxaliplatin (Drug), Pembrolizumab (Drug), Trastuzumab (Drug)
    • Eligibility criteria expanded, about 196 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 63 words
    • Study arms: 2 to 4
    • Study title expanded, about 1 word
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Start date changed from estimate of Aug 2020 to Jul 13, 2020v12
  3. Start date: Jul 2020 to Aug 2020v11
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v10
  5. Start date: Jun 2020 to Jul 2020v9
  6. Start date: May 2020 to Jun 2020v8
  7. Start date: Apr 2020 to May 2020v7
  8. Study description expanded, about 198 wordsv6
  9. Start date: Mar 2020 to Apr 2020v5
  10. Start date: Jan 2020 to Mar 2020v4
  11. Start date: Dec 2019 to Jan 2020v3
  12. Site contact updatedv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
Trial Details
NCT Number NCT04150640
Lead Sponsor University of Wisconsin, Madison
Collaborators: Ipsen
Conditions
(from sponsor)		 Esophageal Adenocarcinoma, Gastric Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov