Evidence map›Paper›PMID 41646480›Full record

ArticleESMO gastrointestinal oncology2025

TROPHIT1-a randomized, open-label, multicenter, phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic colorectal cancer patients.

B C Köhler, G M Haag, L Le Cornet, P Hoffmeister-Wittmann, M Schmidt, A Manjunath, N Vaquero-Siguero, M Jenzer, M Gimmel, A Stahler and 12 more

Abstract read
In one paragraph

Article in ESMO gastrointestinal oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

B C KöhlerDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
G M HaagDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
L Le CornetNCT Trial Center, Heidelberg University Hospital and German Cancer Research Center (DKFZ), Heidelberg.
P Hoffmeister-WittmannDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
M SchmidtDivision of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg.
A ManjunathDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
N Vaquero-SigueroHeidelberg Institute for Stem Cell Technology and Experimental Medicine (HI-STEM gGmbH), Heidelberg.
M JenzerDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
M GimmelDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
A StahlerCharité-Universitätsmedizin Berlin, Berlin.
A SteinHämatologisch Onkologische Praxis Eppendorf (HOPE), Hamburg.
M ReichertTUM School of Medicine and Health, Department of Clinical Medicine-Clinical Department for Internal Medicine II, University Medical Center, Technical University of Munich, Munich.
S KasperDepartment of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen.
M BitzerUniversity Hospital Tübingen, Tübingen.
D JägerDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
C SpringfeldDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
T F WeberDepartment of Radiology, Heidelberg University Hospital, Heidelberg.
S FröhlingGerman Cancer Consortium (DKTK), DKFZ, Core Center Heidelberg, Heidelberg.
K SteindorfDivision of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg.
A TrumppHeidelberg Institute for Stem Cell Technology and Experimental Medicine (HI-STEM gGmbH), Heidelberg.
R F SchlenkDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg.
R JackstadtGerman Cancer Consortium (DKTK), DKFZ, Core Center Heidelberg, Heidelberg.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Colorectal cancer (CRC) ranks among the most common malignancies worldwide. Response rates to standard-of-care (SOC) treatment drop sharply beyond the second treatment line. Trophoblast cell surface antigen-2 (TROP2) acts in a plethora of cellular processes and ectopic expression is detected in a significant percentage of CRCs. Sacituzumab govitecan (SG) is composed of a TROP2-directed antibody armed with the topoisomerase inhibitor SN38. Thus, SG delivers SN38 to TROP2-expressing cancer cells. SG is approved for the treatment of metastatic breast cancer. Phase I/II data revealed a favorable safety profile and early signs of clinical activity in unselected metastatic CRC (mCRC). Patients and methods: TROPHIT1 is an open-label, randomized, multicenter, phase II/III trial to investigate the efficacy of SG in mCRC. Patients being refractory to ≥2 lines of prior therapy and an irinotecan-free interval of at least 6 months are enrolled. In the first part of the study, 20 patients are enrolled in the single-agent SG arm. Upon clinical efficacy in the first part, additional 60 patients are randomized (1 : 1) in the second part to single-agent SG compared with SOC. The primary endpoint is progression-free survival. TROPHIT1 contains a translational research program to unravel the determinants of resistance.

Indexed as

clinical trialpatient-reported outcomeresistancereverse translationTROP2

Identifiers

PMID41646480
PMCPMC12836553

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.