18 and older, any sex, with Metastatic Malignant Neoplasm in the Liver or Stage IV Colorectal Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With Treatment-related, Adverse EventsSecondary· Up to 2 years
Adverse events (AEs) will be analyzed including but not limited to all AEs, serious (S)AEs, and fatal AEs using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 for classification. Due to the potential for late toxicities from pembrolizumab, patients will be followed for 1 year after their last dose of pembrolizumab.
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
1.00
Proportion of Participants With Events of Clinical Interest (ECIs)Secondary· Up to 2 years
Specific immune-related AEs (irAEs) will be collected and designated as immune-related events of clinical interest (ECIs). The study will use descriptive statistics to report on the safety/toxicity. Due to the potential for late toxicities from pembrolizumab, patients will be followed for 1 year after their last dose of pembrolizumab
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
0.33
Proportion of Participants With Perioperative ComplicationsSecondary· Up to 1 month
The proportion of participants with reported perioperative complications related to study treatment will be reported.
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
0.17
Proportion of Participants With an R0 ResectionSecondary· Up to 1 month
Participants who undergo surgical resection of liver metastases will be evaluable and the proportion of participants requiring an R0 resection will be reported
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
0.83
Proportion of Participants With a Pathologic ResponseSecondary· Up to 1 year
Participants who undergo surgical resection of liver metastases will be evaluable and the proportion of participants with a pathological tumor response will be reported
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
0
Median Relapse-free Survival (RFS)Secondary· Up to 2 years from day of surgery
The time from objective response defined as radiographic evidence of relapse on surveillance CT scans after surgery to progression or death, whichever occurs first, will be used to determine relapse-free survival for participants who received adjuvant vactosertib and pembrolizumab.
Group
Value
95% CI
Treatment (vactosertib, pembrolizumab, surgery)
14.51
4.44 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trials studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer that has spread to the liver that can be removed by surgery (resectable hepatic metastases). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vactosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and vactosertib after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. This study also investigates pembrolizumab and vactosertib after liver metastases surgery, decrease the risk of the cancer recurring (coming back).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04705194 — Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging
· unknown
NCT03614546 — Clinical Trial of Radiotherapy in Treating Primary Hepatocellular Carcinoma
· NA
· unknown
NCT03888638 — The Role of Tumor-associated Macrophages in Colorectal Liver Metastases
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chloe Atreya, MD, PhD
Last refreshed: 31 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03844750.