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A randomized, open label, multicenter phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic, refractory colorectal cancer patients (TROPHIT1)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509771-17-00
Acronym
NCT_GI_BCK_01
Enrollment
80
Registered
2024-04-22
Start date
2024-06-04
Completion date
Unknown
Last updated
2025-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal cancer (mCRC)

Brief summary

Progression Free Survival (PFS): as the time from C1D1 (in part 1) or randomization (in part 2) into the study to time of progression of the disease or death from any cause, whatever occurs first.

Detailed description

Overall Survival (OS): as time from C1D1 (in part 1) or randomization (in part 2) until death or end of study (EOS)., Overall Response rate (ORR): Partial Response (PR) or Complete Response (CR), Disease Control Rate (DCR): Complete Response (CR), Partial Response (PR) or Stable Disease (SD), Duration of Response (DOR): as time from achievement of PR/CR until recurrence or progression of the disease or death from any cause

Interventions

DRUGREGORAFENIB
DRUGSACITUZUMAB GOVITECAN
DRUGBEVACIZUMAB

Sponsors

Universitaetsklinikum Heidelberg AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS): as the time from C1D1 (in part 1) or randomization (in part 2) into the study to time of progression of the disease or death from any cause, whatever occurs first.

Secondary

MeasureTime frame
Overall Survival (OS): as time from C1D1 (in part 1) or randomization (in part 2) until death or end of study (EOS)., Overall Response rate (ORR): Partial Response (PR) or Complete Response (CR), Disease Control Rate (DCR): Complete Response (CR), Partial Response (PR) or Stable Disease (SD), Duration of Response (DOR): as time from achievement of PR/CR until recurrence or progression of the disease or death from any cause

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026