deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT03368963

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

A Phase I/II Study of Trifluridine/Tipiracil (TAS102) in Combination With Nanoliposomal Irinotecan (NAL-IRI) in Advanced GI Cancers

Sponsor: Emory University

Conditions Colorectal Adenocarcinoma Gastric Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Non-Resectable Cholangiocarcinoma Stage III Colorectal Cancer Stage III Gastric Cancer Stage III Pancreatic Cancer Stage IV Colorectal Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer Stage IVA Colorectal Cancer Stage IVB Colorectal Cancer Unresectable Digestive System Adenocarcinoma Unresectable Pancreatic Carcinoma
Interventions Nanoliposomal Irinotecan Trifluridine and Tipiracil Hydrochloride
Updated 15 times since 2017 Last updated: Jan 6, 2025 Started: Jan 30, 2018 Primary completion: Jun 28, 2025 Completion: Nov 28, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03368963, this PHASE1/PHASE2 trial focuses on Colorectal Adenocarcinoma and Gastric Adenocarcinoma and remains ongoing. Sponsored by Emory University, it has been updated 15 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Dec 2019 · 12 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Sep 2020 · 7 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Feb 2023 · 12 months · monthly snapshot~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – present · 17 months · monthly snapshot

Change History

15 versions recorded

  1. Feb 2025 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Sep 2024 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Feb 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  5. Feb 2023 — Feb 2024 [monthly]

    Recruiting PHASE1_PHASE2

▶ Show 10 earlier versions

  1. Feb 2022 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  4. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  5. Feb 2020 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

  6. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE1_PHASE2

  7. Dec 2018 — Dec 2019 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  9. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  10. Dec 2017 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Emory University
  • Ipsen
  • Taiho Oncology, Inc.
Data source: Emory University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations