Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether regorafenib, a drug that blocks several cancer-growth signals, together with lorigerlimab, an immune-checkpoint drug designed to activate immune attack, can reduce circulating tumour DNA (ctDNA)—small tumour-derived DNA fragments in the blood—in people with colorectal cancer that is not visible on scans but may remain after definitive treatment.
The idea is that treating this molecular residual disease early might make ctDNA fall or disappear, rather than waiting for cancer to become visible on scans. This trial mainly measures safety and side effects, with changes in ctDNA as an indicator of the treatment’s effect; it has no comparison group and does not directly test longer survival or time before recurrence.
Worth knowing: This is a small, non-randomised phase 2 trial of 16 people, and ctDNA changes may not translate into longer survival or prevent recurrence.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07071961 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 16 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | M.D. Anderson Cancer Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Regorafenib (CT)
- Drug Lorigerlimab
What it is measuring
Safety and adverse events (AEs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
To learn about the effects of the drugs regorafenib and lorigerlimab on circulating tumor DNA (ctDNA) in patients with CRC and who have radiographic occult minimal residual disease (MRD) after completing standard-of-care therapy
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Eligibility Criteria
- Histological confirmation of CRC
- Post-R0 resection of stages II, III, or IV CRC and all planned adjuvant therapies have been completed.
- No evidence of radiographic disease within 28 days (before or after) of a positive ctDNA assay
- Evident MRD as defined by positive ctDNA assay. Participants may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count: ≥1,000/mcL
- Platelets: ≥100,000/mcL
- Total bilirubin ≤1.5 x the upper limit of normal (ULN). Total bilirubin (≤3 x ULN) is allowed if Gilbert's syndrome is documented.
- AST(SGOT)/ALT(SGPT): ≤3 × institutional ULN (≤5 x ULN for participants with liver involvement of their cancer).
- Creatinine clearance ≥40 mL/min. Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = [(140 – age) x (weight in kg) ÷ [72 x (serum creatinine in mg/dL)] [0.85 if female]
- ECOG performance status (PS) of 0 or 1
- Age ≥ 18 years.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07071961, registered by M.D. Anderson Cancer Center on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.